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Biocon
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More news about Biocon
05May 26
Biocon Anticipates Margin Pressure for Insulin Glargine
Biocon has signaled anticipated margin pressure for its Insulin Glargine product, as reported by NDTV. The disclosure highlights potential challenges in the profitability of this biosimilar within the company's portfolio. No specific financial figures or timeframes were included in the available source information.
01May 26
Biocon: U.S. FDA Completes Pre-License Inspection At Biosimilars Plant
Biocon Limited successfully completed a U.S. FDA Pre-License Inspection at its biosimilars manufacturing facility in Bengaluru from April 20-29, 2026. The inspection covered 3 biologics manufacturing units, 5 quality testing laboratories, and 2 warehouses. The FDA issued a Form 483 with five procedural observations, notably with no data integrity issues or repeat observations from previous inspections. The company filed an official statement with stock exchanges on April 30, 2026, and committed to addressing all observations through a comprehensive CAPA plan within the FDA's stipulated timeline.
29Apr 26
Biocon Limited Publishes Newspaper Advertisements for Second 100 Days Campaign 'Saksham Niveshak'
Biocon Limited published newspaper advertisements on April 28, 2026, in Financial Express and Vijayavani as part of the Second 100 Days Campaign 'Saksham Niveshak' launched by the IEPF Authority. The campaign aims to help shareholders update KYC and bank details to claim unpaid/unclaimed dividends before transfer to IEPF. The company has submitted advertisement copies to BSE and NSE under SEBI regulatory compliance requirements.
26Apr 26
Biocon Limited Board Meeting intimation for Q4FY26 under Regulation 29 scheduled on 2026-05-07
Biocon Limited has filed regulatory intimation under SEBI LODR Regulation 29(1) for board meeting on May 07, 2026 to approve audited Q4 and FY26 financial results. The company has implemented trading window closure from April 01-May 09, 2026 for insider trading compliance. An earnings conference call is scheduled for May 08, 2026 at 09:00 hrs IST via Zoom, with recordings and transcripts to be made available within specified timelines.
22Apr 26
Biocon Receives Health Canada Approval for Biosimilars Bosaya and Vevzuo
Biocon Limited announced Health Canada's approval of Bosaya™ and Vevzuo™, denosumab biosimilars for treating osteoporosis and cancer-related bone conditions. The approval covers multiple patient populations including postmenopausal women, men with osteoporosis, and cancer patients with bone metastases, potentially benefiting over 2 million adults with osteoporosis and hundreds with bone metastasis annually.
22Apr 26
Biocon Limited Issues KYC Compliance Reminder to Physical Shareholders Under SEBI Regulations
Biocon Limited has issued a compliance reminder to physical shareholders regarding mandatory KYC updates as per SEBI Master Circular dated February 06, 2026. The company warns that dividend payments may be withheld for non-compliant folios and has outlined specific documentation requirements including Form ISR-1 and Form ISR-2 submissions through multiple channels including courier, electronic mode, or web portal via registrar KFin Technologies Limited.
20Apr 26
HSBC Maintains Buy Rating on Biocon with ₹425 Target Price on Strong Growth Foundation
HSBC has reaffirmed its Buy rating on Biocon with a target price of ₹425, highlighting the company's strengthened foundation through debt reduction and corporate simplification. The investment bank identifies execution of new biosimilar launches, improving profitability metrics, enhanced cash flow generation, and market share gains in biosimilars as key growth catalysts for the biotechnology company.
08Apr 26
Biocon Limited Schedules Investor Meetings at HSBC Global Investment Summit 2026 and Singapore Roadshow
Biocon Limited has scheduled investor meetings at the HSBC Global Investment Summit 2026 in Hong Kong on April 14-15, 2026, and an investor roadshow in Singapore on April 16-17, 2026. The company will conduct one-on-one and group meetings with analysts and institutional investors while ensuring no unpublished price sensitive information is disclosed during these interactions.
08Apr 26
Biocon Limited Submits Q4 FY26 Certificate Under SEBI Depositories Regulations
Biocon Limited filed its mandatory quarterly certificate under SEBI Regulation 74(5) for Q4 FY26 on April 07, 2026, covering the quarter ended March 31, 2026. The certificate confirms compliance with dematerialization and rematerialization requirements, with registrar KFin Technologies Limited providing confirmation of proper handling of all demat processes including timely request processing and register maintenance.
08Apr 26
Biocon Announces U.S. Launch Of Bosaya™ And Aukelso™ Denosumab Biosimilars
Biocon Limited has commercially launched two denosumab biosimilars, Bosaya™ and Aukelso™, in the United States following FDA approval with interchangeable designation. These products target significant patient populations with osteoporosis and bone metastasis, entering a $5 billion market segment while expanding Biocon's biosimilars portfolio in oncology and immunology therapeutics.
07Apr 26
Biocon Ltd Records ₹47.97 Crore Block Trade on NSE at ₹349.00 Per Share
Biocon Ltd witnessed significant institutional trading activity with a block trade worth ₹47.97 crores on NSE. The transaction involved approximately 1,374,453 shares priced at ₹349.00 per share, reflecting routine institutional portfolio adjustments and demonstrating strong liquidity in the company's stock.
30Mar 26
Biocon Limited Announces Name Change of Irish Step-Down Subsidiary
Biocon Limited has announced the name change of its step-down subsidiary from Biosimilar Collaborations Ireland Limited to Biocon Biologics Ireland Limited, effective March 27, 2026. The information was received from material subsidiary Biocon Biologics Limited on March 29, 2026, and formally communicated to stock exchanges on March 30, 2026, under Regulation 30 compliance requirements.
27Mar 26
Biocon Limited Submits Employee Welfare Trust Amendment Deed with Trustee Changes
Biocon Limited has submitted Amendment #7 to its Employee Welfare Trust deed, executed on March 27, 2026, involving changes to the Trust's Board of Trustees. Mr. Krishnachar Nandakumar and Ms. Maninder Kapoor Puri will resign as trustees effective March 31, 2026, and will be replaced by Mr. Mukesh Kamath and Mr. Naveen Narayanan from April 01, 2026. The amendment modifies Article 8 of the trust deed and has been submitted to stock exchanges in compliance with SEBI regulations.
27Mar 26
Biocon Limited Appoints Shreehas Tambe as CEO in Major Leadership Transition
Biocon Limited announced major leadership changes with Shreehas Tambe appointed as CEO & Managing Director and Kedar Upadhye as CFO, effective April 1, 2026. This transition supports the integration of Biocon Biologics as a wholly owned subsidiary, creating a unified corporate structure. Under Tambe's leadership at Biocon Biologics, the company achieved USD 5.50 billion valuation and became a Top 5 global biosimilar company by revenue.
13Mar 26
Biocon Arm Biocon Pharma Limited Wins U.S. FDA Approval For Liraglutide Injection
Biocon Limited announced that its wholly-owned subsidiary Biocon Pharma Limited has received U.S. FDA approval for Liraglutide Injection (gVictoza®) ANDA, designed for Type 2 diabetes treatment in adults, adolescents and children aged 10 years and above. This marks the company's second Liraglutide-based product approval in recent weeks, following the earlier gSaxenda® approval, significantly strengthening Biocon's complex drug portfolio and positioning in the U.S. diabetes treatment market.
12Mar 26
Biocon Reports 9.2% Revenue Growth in Q3FY26 with Strong Profitability Recovery
Biocon Limited reported strong Q3FY26 results with consolidated revenue growing 9.2% YoY to ₹41,730 million. Net profit attributable to shareholders surged to ₹1,438 million from ₹251 million, while basic EPS improved significantly to ₹1.08. Nine-month revenue reached ₹1,24,104 million with net profit of ₹2,597 million, reflecting the company's operational strength and market expansion.
09Mar 26
FDA Reduces Regulatory Requirements for Biosimilar Drug Manufacturers
The FDA has reduced regulatory requirements for companies developing biosimilar versions of expensive biologic drugs. This policy change aims to streamline the approval process for cheaper alternatives to costly biologic medications. The development could benefit pharmaceutical companies like Biocon that specialize in biosimilar drug development and manufacturing.
05Mar 26
Biocon Limited to Participate in JP Morgan's Annual India Credit Investor Trip on March 11, 2026
Biocon Limited has announced its participation in JP Morgan's annual flagship India Credit Investor Trip on March 11, 2026, through a virtual group interaction format. The company informed stock exchanges under Regulation 30(6) of SEBI Listing Regulations and confirmed that no Unpublished Price Sensitive Information will be disclosed during the meeting. The event details will be available on the company's website, and the schedule remains subject to change due to potential exigencies.
04Mar 26
Biocon Invests ₹315 Crore in Biocon Biosphere and Biocon Pharma Using OCRPS
Biocon Limited has completed a ₹315 crore investment in its wholly owned subsidiaries Biocon Biosphere Limited and Biocon Pharma Limited through Optionally Convertible Redeemable Preference Shares. The investment aims to support ongoing business operations, working capital needs, and general corporate purposes while maintaining full ownership of both pharmaceutical manufacturing entities.
25Feb 26
Biocon Secures U.S. FDA Approval For Weight Loss Drug Liraglutide With $127M Market
Biocon Limited has secured U.S. FDA approval for its Liraglutide Injection (gSaxenda®) for chronic weight management, marking a significant regulatory milestone. The GLP-1 therapy targets a US $127 million market opportunity and represents validation of Biocon's complex formulation capabilities in the fast-growing weight management therapeutic segment.
13Feb 26
Biocon Shares Q3FY26 Earnings Call Recording Link Under Regulation 30
Biocon Limited has made available the audio and video recordings of its Q3FY26 earnings call conducted on February 13, 2026, in compliance with SEBI Regulation 30. The company reported mixed Q3FY26 results with revenue growth of 10.4% to ₹6,213M but posted a standalone net loss of ₹764M due to exceptional items worth ₹1,963M.
07Feb 26
Fitch Ratings Upgrades Biocon Biologics Outlook to Positive, Affirms BB- Rating
Fitch Ratings has revised Biocon Biologics' outlook to positive while maintaining its BB- rating, citing expectations of sustained financial leverage reduction. The company, serving over 6.3 million patients across 120+ countries with 10 commercialized biosimilars, also received affirmation of its BB rating on USD 800 million secured notes.
30Jan 26
Biocon Limited Completes Rs. 2,000 Crore Commercial Paper Buyback
Biocon Limited successfully completed the buyback of commercial papers totaling Rs. 2,000.00 crore on January 30, 2026, comprising two separate issues under ISINs INE376G14040 (Rs. 1,800.00 crore) and INE376G14057 (Rs. 200.00 crore). The company fulfilled all regulatory requirements under SEBI Master Circular and confirmed adherence to FIMMDA guidelines.
28Jan 26
Biocon Limited Receives VAI Status from US FDA for API Facility Inspection
Biocon Limited has received a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration for its API facility in Andhra Pradesh. The status follows an inspection conducted between November 3rd and 7th, 2025. The company has notified both BSE and NSE about this regulatory development as per Regulation 30 compliance requirements.
28Jan 26
S&P Global Upgrades Biocon Biologics Credit Rating to 'BB+' with Stable Outlook
S&P Global Ratings upgraded Biocon Biologics' credit rating to 'BB+' from 'BB' with stable outlook following successful capital restructuring. The upgrade reflects simplified capital structure through US$460 million equity issuance to settle US$1 billion CCPS with Viatris Inc. S&P projects significant debt reduction from INR248 billion to INR115 billion and FFO-to-debt ratio improvement to 22% by fiscal 2026, reaching 30% by fiscal 2027. The stable outlook is supported by expected revenue growth of 15% in biosimilars business and new product launches including Denosumab.
20Jan 26
SBI Mutual Fund Increases Biocon Stake to 7.04% Through Strategic Share Acquisition
SBI Mutual Fund has substantially increased its stake in Biocon Ltd to 7.0379% from 5.3445% by acquiring 3.35 crore shares on January 16, 2026. The acquisition, executed through qualified institutional placement and market purchases, triggered mandatory SEBI disclosure requirements due to the 2% shareholding increase. This strategic investment demonstrates institutional confidence in the biotechnology company's prospects.
15Jan 26
Biocon Completes ₹4,150 Crore QIP with Major Allocation to SBI, ICICI Funds
Biocon successfully raised ₹4,150 crores through QIP, issuing 112.66 crore shares at ₹368.35 each. Major allocation went to SBI and ICICI Prudential MF with 29.51% each. The funds will primarily support the acquisition of remaining Biocon Biologics shares from Mylan Inc., making it a wholly-owned subsidiary.
15Jan 26
Biocon Completes ₹41,500 Crore QIP Issue with Allotment of 11.27 Crore Equity Shares
Biocon Limited successfully completed its QIP issue on January 14, 2026, allotting 11,26,64,585 equity shares at ₹368.35 per share to raise ₹41,500 million. The issue saw strong participation from major mutual fund houses including SBI, ICICI Prudential, and Mirae Asset funds. The capital raise increased Biocon's paid-up share capital to ₹8,10,45,38,865 with total equity shares reaching 1,62,09,07,773.
14Jan 26
Biocon Limited Fund Raising Committee Approves Placement Document for Qualified Institutions Placement
Biocon Limited's Fund Raising Committee approved the Placement Document for its Qualified Institutions Placement on January 14, 2026, during a meeting held from 10:12 p.m. to 10:20 p.m. The QIP involves equity shares with ₹5 face value and complies with SEBI ICDR Regulations and Companies Act provisions. The company has informed BSE and NSE about this development as part of regulatory compliance under Regulation 30.
14Jan 26
Biocon Completes ₹4,151 Crore QIP with Allotment of 11.27 Crore Shares at ₹368.35 Each
Biocon Limited successfully completed its Qualified Institutions Placement on January 14, 2026, allotting 11,26,64,585 equity shares at ₹368.35 per share to qualified institutional buyers. The issue price represented a 5.00% discount to the floor price of ₹387.74, raising approximately ₹4,151 crores for the pharmaceutical company. The QIP opened on January 12, 2026 and closed within two days, demonstrating strong institutional investor interest and efficient execution under SEBI regulations.
13Jan 26
Biocon Limited Schedules Board Meeting and Earnings Conference Call for Q3FY26 Results
Biocon Limited has scheduled its Board of Directors meeting for February 12, 2026 to approve Q3FY26 financial results for the quarter and nine months ended December 31, 2025. The company will conduct an earnings conference call for analysts and investors on February 13, 2026 at 09:00 hrs IST via Zoom platform. Trading window for the company's securities remains closed from January 1-14, 2026, reopening on February 15, 2026.
13Jan 26
Biocon QIP to ease balance sheet pressure; metals, PSU banks favoured in near term: Nischal Maheshwari
Market expert Nischal Maheshwari views Biocon's equity raise positively despite ₹5,000 crore debt concerns, expecting strong cash flows to manage debt over 2-3 years while QIP funds BBL stake buyout. He favours PSU banks for short-term gains and private banks for medium-term investment, while highlighting opportunities in metals and power sector EPC players following recent corrections.
12Jan 26
Biocon Opens ₹4,500-Crore QIP To Fund Biologics Integration
Biocon Ltd. launched a ₹4,500 crore QIP at ₹387.74 floor price to fund the integration of Biocon Biologics, with ₹3,620 crore allocated for Mylan's $815 million stake acquisition. The deal combines $400 million cash payment and $415 million share swap, targeting completion by March 2026 to create a unified global biopharma leader in diabetes, oncology, and immunology markets.
12Jan 26
Biocon Launches ₹4,500 Crore QIP Following Board and Shareholder Approvals
Biocon has launched its Qualified Institutional Placement on January 12, 2026, targeting ₹4,500.00 crores in capital raising. The pharmaceutical company obtained necessary board and shareholder approvals last month before initiating this significant institutional fundraising exercise. The QIP provides Biocon access to qualified institutional investors for strengthening its capital base.
12Jan 26
Biocon launches ₹4,150-crore QIP with floor price set at ₹387.74 per share
Biocon Limited has launched a ₹4,150-crore QIP with a floor price of ₹387.74 per share, approved by the board on 6 December 2025 and opened on 12 January 2026. The company may offer up to 5% discount per SEBI regulations, with an indicative issue price of ₹368.35. Stock closed at ₹370.90 on 12 January 2026, down 2.29%, trading below the floor price. Recent developments include subsidiary's plans for three new oncology biosimilars and a licensing agreement with Ajanta Pharma for semaglutide marketing across 26 countries.
12Jan 26
Biocon Sets Floor Price at ₹387.74 Per Share for Equity Transaction
Biocon has set a floor price of ₹387.74 per share for its equity transaction, establishing a minimum valuation threshold. This mechanism provides price protection and demonstrates the company's commitment to maintaining appropriate share valuations during the offering process.
12Jan 26
Biocon Limited Opens Qualified Institutions Placement at ₹387.74 Floor Price Per Share
Biocon Limited has launched its Qualified Institutions Placement with a floor price of ₹387.74 per equity share, following approvals from the Board of Directors on December 06, 2025, and shareholders on December 31, 2025. The Fund Raising Committee authorized the QIP opening on January 12, 2026, with the flexibility to offer up to 5% discount on the floor price. The final issue price will be determined in consultation with book running lead managers, while trading window restrictions remain in place for compliance with insider trading regulations.
12Jan 26
Biocon Receives USFDA Approval for Everolimus Tablets in Multiple Strengths
Biocon has obtained USFDA approval for Everolimus tablets in 2mg, 3mg, and 5mg strengths for treating Tuberous Sclerosis Complex and SEGAs. This regulatory milestone expands Biocon's oncology portfolio in the US market and provides healthcare providers with flexible dosing options for rare neurological conditions.
12Jan 26
Biocon Subsidiary Receives U.S. FDA Approval for Everolimus Tablets in Multiple Strengths
Biocon Limited's subsidiary Biocon Pharma Limited has received U.S. FDA approval for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg, and 5 mg strengths. The medication is indicated for treating adult and pediatric patients with Tuberous Sclerosis Complex conditions, including SEGA and TSC-associated seizures. The approval strengthens Biocon's vertically integrated drug product portfolio.
08Jan 26
Biocon Executive Chairperson Criticizes Andhra Pradesh's 75% Local Employment Mandate
Kiran Mazumdar-Shaw, Executive Chairperson of Biocon Ltd, has criticized the Andhra Pradesh Employment of Local Candidates in Industries/Factories Act, which reserves 75% of private sector jobs for eligible locals. The Act, enacted in 2019 and enforced since October 2019, has sparked debate between advocates of skill-based hiring and supporters of regional employment security. Mazumdar-Shaw argues that such mandates are detrimental to businesses, while critics contend that local job reservations are justified given government incentives provided to companies.
06Jan 26
Biocon Biologics Unveils Three Major Oncology Biosimilars at J.P. Morgan Conference
Biocon Biologics announced three major oncology biosimilars including Trastuzumab/Hyaluronidase, Nivolumab, and Pembrolizumab at the J.P. Morgan Healthcare Conference, representing substantial market opportunities totaling over $75 billion. The company outlined strategic integration plans as a wholly owned subsidiary of Biocon Limited, expected to complete by March 31, 2026, while Biocon shares closed down 1.21% at ₹386.60.
06Jan 26
Biocon Completes BBL Acquisition as Mylan Files SEBI Disclosure for 6.10% Stake
Biocon Limited successfully completed its strategic acquisition of Biocon Biologics Limited, acquiring 33.38 crore BBL shares and allotting 17.13 crore equity shares to investors including Mylan Inc., which received 9.20 crore shares representing 6.10% stake and filed mandatory SEBI disclosure.
02Jan 26
Biocon Issues ₹2,000 Crore Commercial Papers for Short-Term Funding
Biocon has issued commercial papers worth ₹2,000 crores as part of its short-term funding strategy. Commercial papers are unsecured debt instruments used by companies to meet immediate working capital and operational requirements, providing financial flexibility for business operations.
02Jan 26
Biocon Limited Issues ₹200 Crore Commercial Papers on Private Placement Basis
Biocon Limited has issued Commercial Papers worth ₹200 crores on private placement basis with 6.80% interest rate and 60-day tenure. The papers, allotted on January 2, 2026, will mature on March 3, 2026, and are proposed for listing on NSE. The entire issue has been allocated to Kotak Mahindra funds with IND A1+ credit rating and no security created over company assets.
24Dec 25
Biocon Declares Record Date for ₹1,800 Crore Commercial Paper Maturity
Biocon Limited has declared March 19, 2026 as the record date for its ₹1,800 crore commercial paper maturity, one day before the March 20, 2026 maturity date. The commercial paper, with ISIN INE376G14040, carries a 6.85% coupon rate and was issued on December 22, 2025, with allotment to prominent mutual fund houses including SBI, Axis, and Aditya Birla Sun Life liquid funds.
23Dec 25
Biocon Partners With Ajanta Pharma to Market Semaglutide Across 26 International Markets
Biocon has formed a strategic partnership with Ajanta Pharma to market semaglutide, a diabetes treatment medication, across 26 international markets. This collaboration aims to expand Biocon's diabetes treatment portfolio globally, leveraging combined expertise and distribution networks to reach patients in multiple countries.
23Dec 25
Biocon Biologics Secures Full Global Rights to Biosimilar Adalimumab from FKB
Biocon Biologics has announced securing full and exclusive global rights for biosimilar adalimumab (Hulio) from FKB, superseding their previous commercialization-only agreement. The enhanced deal grants end-to-end control over manufacturing, commercialization, and development activities, with FKB participating in development costs while receiving technology license fees and royalties. Commercial production will begin following technology transfer and regulatory approvals, strengthening Biocon's position in the global immunology biosimilars market.
19Dec 25
Biocon Receives EIR With VAI Status From U.S. FDA For New Jersey Facility
Biocon has received an EIR with VAI status from the U.S. FDA for its Cranbury, New Jersey facility following an October cGMP inspection. The VAI classification indicates that while the FDA identified areas for improvement, these observations do not require immediate regulatory enforcement action, allowing Biocon to address them through voluntary corrective measures.
17Dec 25
Biocon Biologics Named Asia IP Elite 2025 by IAM for Ninth Consecutive Year
Biocon Biologics Limited has been named an Asia IP Elite for 2025 by Intellectual Asset Management (IAM), marking the ninth consecutive year for Biocon entities. The award, presented at IPBC Asia in Tokyo, recognizes exceptional IP value creation. Biocon Biologics, serving over 6.30 million patients across 120 countries, has commercialized 10 biosimilars and maintains a pipeline of 20 biosimilar assets. CEO Shreehas Tambe emphasized the company's commitment to innovation and expanding access to affordable therapies globally.
16Dec 25
Biocon Gets Credit Rating Reaffirmation from CRISIL
Biocon Limited has received a credit rating reaffirmation from CRISIL Ratings Limited for its bank loan facilities of ₹250.00 crores. CRISIL has maintained Biocon's long-term rating at CRISIL AA/Stable and short-term rating at CRISIL A1+. The reaffirmation indicates high safety for timely servicing of financial obligations and the highest degree of safety for short-term debt obligations. This information was disclosed to stock exchanges in compliance with SEBI regulations.
16Dec 25
Biocon Announces $1.17 Billion BBL Acquisition, Maintains ICRA [AA] Rating
Biocon Limited has announced a major $1.17 billion acquisition to make Biocon Biologics Limited its wholly-owned subsidiary by acquiring minority stakes from Mylan Inc., Serum Institute Life Sciences, Tata Capital, and Activ Pine. The transaction will be funded through a combination of share swap worth $773 million and cash payment of $400 million, with funding structured through commercial paper and a ₹4,500 crore QIP. ICRA Limited has simultaneously reaffirmed Biocon's credit ratings at [AA] (Stable)/A1+ for ₹450 crore unallocated facilities, noting the strategic benefits of corporate structure simplification and expected operational synergies across the biopharmaceutical operations.
15Dec 25
Biocon Limited Launches GLP-1 Drug Liraglutide in Netherlands After MEB Approval
Biocon Limited has successfully launched its GLP-1 peptide Liraglutide in the Netherlands following approval from the Dutch Medicines Evaluation Board (MEB). The drug will be marketed under two registered brand names - Diavorin® for diabetes management and Vobexoryn® for obesity treatment - through distribution partner Pharmamedicb B.V. This represents Biocon's first European Union market entry under its own brand names, demonstrating the company's vertically integrated capabilities and commitment to expanding access to advanced metabolic treatments.
13Dec 25
Biocon Biologics Secures Global Settlement Agreement for YESAFILI Launch
Biocon Biologics has reached a settlement and license agreement with Regeneron and Bayer for worldwide commercialization of its biosimilar aflibercept, YESAFILI. The agreement allows for a UK launch in January 2026 and other countries in March 2026. YESAFILI, approved by EC and MHRA, treats various ophthalmology conditions. This expands Biocon's ophthalmology portfolio and global presence.
11Dec 25
S&P Global Places Biocon Biologics on Positive Credit Watch Following Accelerated Debt Reduction
S&P Global Ratings placed Biocon Biologics on positive credit watch on December 10, 2025, recognizing accelerated debt reduction progress. The company's BB long-term issuer credit rating and senior secured notes rating received positive outlook following Biocon's plan to make Biocon Biologics wholly owned through minority investor buyouts. S&P expects Biocon's adjusted debt to fall from ₹248 billion to ₹120 billion by March 2026, funded by ₹45 billion fresh equity issuance.
04Dec 25
Biocon to Explore Fundraising Options and Invest in Biocon Biologics
Biocon, a biopharmaceutical company, is considering raising funds through commercial paper or share issuance. Simultaneously, the company plans to invest in its subsidiary, Biocon Biologics, by purchasing securities from existing shareholders. Biocon's recent financial data shows growth in total assets (4.86%), current assets (7.29%), investments (12.73%), and total equity (9.64%) compared to the previous year.
02Dec 25
Biocon Announces December 2025 Launch for Denosumab Biosimilars in Europe and Worldwide
Biocon has announced the launch of its denosumab biosimilars, Vevzuo® and Evfaxy®, in European and global markets on December 2, 2025. The company has secured an agreement with Amgen for sales permission. These biosimilars, used for treating osteoporosis and preventing skeletal-related events in cancer patients, represent a significant expansion of Biocon's biosimilar portfolio and global market presence.
19Nov 25
Biocon Pharma Secures FDA Approval for Tofacitinib Extended-Release Tablets
Biocon Limited's subsidiary, Biocon Pharma Limited, has received FDA approval for Tofacitinib Extended-Release Tablets. The 11mg strength received final approval, while the 22mg strength got tentative approval. Tofacitinib, a JAK inhibitor, is used to treat chronic inflammatory conditions like rheumatoid arthritis and ulcerative colitis. This approval strengthens Biocon's complex drug products portfolio and expands its presence in the U.S. pharmaceutical market for chronic disease management.
18Nov 25
Biocon Reports Strong Q2 FY26 Results: 20% Revenue Growth Led by Biosimilars
Biocon Limited reported robust Q2 FY26 results with operating revenue up 20% YoY to INR 4,296 crores. Core EBITDA grew 23% to INR 1,218 crores, while EBITDA margin reached 21%. Biosimilars segment led growth with 25% revenue increase. The company reduced debt, launched new biosimilars, and expanded its generics and CRDMO businesses. Biocon expects continued margin improvement and growth across segments.
13Nov 25
SBI Mutual Fund Increases Stake in Biocon; Shares Hit 52-Week High Amid Merger Speculation
SBI Mutual Fund has acquired 370,150 shares of Biocon on November 11, 2025, increasing its stake from 4.97% to 5.00%. The fund now holds 66,865,887 shares in the biopharmaceutical company. This acquisition has triggered disclosure requirements due to crossing the 5% threshold. Biocon's total equity share capital consists of 1,336,963,635 equity shares with a face value of Rs. 5 each. The company recently held its Q2 FY26 Earnings Call on November 12, 2025.
11Nov 25
Biocon's Q2 Net Profit Soars to ₹1.3 Billion, Outperforming Estimates
Biocon reported a consolidated net profit of ₹1.30 billion for Q2 FY2024, a 379.7% increase from ₹0.27 billion in Q2 FY2023, exceeding analyst estimates of ₹0.75 billion. Revenue rose 19.6% to ₹42.95 billion, while EBITDA grew 21.9% to ₹8.35 billion. The company plans to acquire Compulsorily Convertible Debentures of Biocon Biologics for ₹3.00 billion, indicating strategic expansion in the biologics segment.
08Nov 25
Biocon's Visakhapatnam API Facility Receives Two Observations from US FDA Inspection
Biocon Limited's API facility in Visakhapatnam underwent a GMP surveillance inspection by the US FDA from November 3-7, 2025. The inspection resulted in two observations, which Biocon plans to address within the stipulated timeframe. The company stated that these observations are not expected to impact its business operations. Biocon has notified the BSE and NSE about the inspection outcome as part of its regulatory disclosure.
23Oct 25
Biocon Biologics Expands North American Presence with Health Canada Approval for Ustekinumab Biosimilar
Biocon Biologics Ltd (BBL) received approval from Health Canada for Yesintek™ and Yesintek™ I.V., biosimilars to Stelara® (ustekinumab). The products will be commercially available in mid-October 2025 for treating various conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. This approval marks BBL's entry into the Canadian market, expanding its North American presence and immunology portfolio. The company plans to support patients through the My Biocon Biologics™ program and aims to improve biosimilar adoption in Canada's public and private markets.
21Oct 25
Biocon Chief Meets Karnataka Leadership, Pledges Support for Bengaluru Development
Kiran Mazumdar-Shaw, Biocon chief, met with Karnataka's top leadership, including CM Siddaramaiah and Deputy CM D K Shivakumar, to discuss Bengaluru's development. Mazumdar-Shaw assured cooperation for the city's progress. The government plans to meet with IT/BT industry leaders and visit local bodies near Greater Bengaluru. These meetings, which included interactions with opposition leaders, aim to address the city's infrastructure challenges collaboratively.
16Oct 25
Biocon Biologics Expands U.S. Insulin Market Reach Through Enhanced Civica Partnership
Biocon Biologics, a Biocon Ltd. subsidiary, has expanded its partnership with Civica to increase affordable insulin supply in the US. The multi-year agreement focuses on bringing a new Insulin Glargine medicine to the market. Biocon Biologics will manufacture and supply the product, while Civica will handle commercialization under its own label. The collaboration aims to address the needs of 38.4 million diabetes patients in the US. Biocon Biologics, ranked as the fourth largest insulin company globally, provides over 9.2 billion doses of insulin worldwide.
14Oct 25
Biocon Shares Worth Rs. 22.49 Crores Traded in NSE Block Deal
Biocon Ltd. experienced a significant block trade on the NSE, involving 642,850 shares at Rs. 349.80 per share, totaling Rs. 22.49 crores. The company recently submitted its regulatory compliance certificate under SEBI regulations, confirming timely completion of dematerialization requests and proper recording of securities.
11Oct 25
Biocon's New Jersey Facility Completes FDA Inspection with Single Observation
Biocon Limited's newly inaugurated manufacturing facility in Cranbury, New Jersey, underwent a Good Manufacturing Practice (GMP) inspection by the U.S. FDA. The inspection concluded with a single observation, which Biocon plans to address within the stipulated timeframe. The company does not anticipate any impact on its business operations. The Cranbury facility, inaugurated in September, is a key part of Biocon's U.S. expansion strategy, supporting capacity expansion and supply chain efficiency. Some products are already commissioned at the site, with additional launches planned. This facility aims to enable faster access to Biocon's vertically integrated portfolio, aligning with the company's mission to expand access to affordable therapies.
07Oct 25
Biocon's Subsidiary Secures USFDA Tentative Approval for Rifaximin Tablets
Biocon Pharma Limited, a subsidiary of Biocon Limited, in partnership with Carnegie Pharmaceuticals LLC, has received tentative approval from the U.S. FDA for their ANDA for Rifaximin Tablets (550 mg). Rifaximin is used to reduce hepatic encephalopathy recurrence risk and treat irritable bowel syndrome with diarrhea in adults. This approval is a significant step towards entering the U.S. market, though final approval and launch may be subject to additional requirements.
01Oct 25
Biocon Completes Early Redemption of Rs 1,070 Crore Non-Convertible Debentures
Biocon Limited has approved the early redemption of Non-Convertible Debentures (NCDs) worth Rs 1,070.00 crore. The Board of Directors made this decision on October 1, 2025, for 107,000 unlisted, secured, rated, redeemable NCDs originally issued on February 21, 2023. The company has completed the payment to debenture holders and the trustee, demonstrating its strong liquidity position. This move is expected to improve Biocon's debt profile and potentially reduce interest expenses.
01Oct 25
Biocon Biologics Secures U.S. Market Entry for Denosumab Biosimilars
Biocon Biologics Ltd. (BBL) has reached a settlement with Amgen Inc., allowing the launch of its denosumab biosimilars, Bosaya™ and Aukelso™, in the U.S. from October 1, 2025. The FDA approved both biosimilars in September 2025 with provisional interchangeability designation. Bosaya™ treats various forms of osteoporosis, while Aukelso™ is indicated for skeletal-related events in cancer patients. This move strengthens BBL's oncology portfolio and marks its entry into the bone health market, addressing significant health concerns affecting millions of Americans.
25Sept 25
Biocon Faces Rs. 2.02 Crore Tax Demand from Karnataka Commercial Tax Department
Biocon Limited has received a Show Cause Notice from Karnataka's Office of the Deputy Commissioner of Commercial Taxes, proposing a total demand of Rs. 2.02 crore for FY 2021-22. The demand includes Rs. 81.38 lakh in tax, Rs. 1.13 crore in interest, and Rs. 8.14 lakh in penalties. The notice outlines seven tax-related issues, including incorrect turnover reduction, short declaration of outward supplies, and input tax credit mismatches. Biocon states there is no material impact on its financials or operations and is taking appropriate actions to address the notice.
19Sept 25
Biocon Limited Fulfills Rs. 600 Crore Commercial Paper Buyback Obligation
Biocon Limited has successfully completed the buyback of Commercial Papers worth Rs. 600 crores on September 19, 2025. The CPs, originally issued on April 22, 2025, were used for refinancing existing borrowings. The company confirmed full compliance with regulatory requirements, maintaining standard asset classification for fund-based facilities, and reported no material changes in its financial status that could affect the CP's credit rating.
18Sept 25
Biocon Biologics' Yesafili Secures Funded Access in Ontario's Public Drug Program
Biocon Biologics' biosimilar drug Yesafili (aflibercept) has been included in Ontario's Public Drug Formulary. This inclusion provides funded access to the treatment for patients with retinal diseases in Canada's most populous province. Yesafili, used for conditions like age-related macular degeneration and diabetic macular edema, offers a more affordable alternative to the original biologic drug. This development expands access to treatment, potentially reducing costs for patients and the healthcare system. For Biocon Biologics, this represents a significant market opportunity in Canada and strengthens its position in the global biosimilars market.
17Sept 25
Biocon Sets Record Date for Rs. 600 Crore Commercial Paper Buyback
Biocon Limited announced September 18, 2025, as the record date for a Rs. 600 crore Commercial Paper buyback. Simultaneously, its subsidiary, Biocon Biologics Ltd., received FDA approval for two denosumab biosimilars: Bosaya™ and Aukelso™. These biosimilars, alternatives to Prolia® and Xgeva®, have been granted provisional interchangeability designation. The original products had nearly $5 billion in U.S. sales in 2024.
17Sept 25
Biocon Biologics Secures FDA Approval for Two Denosumab Biosimilars, Expanding Its Portfolio
Biocon Biologics Ltd. (BBL) has received FDA approval for Bosaya™ and Aukelso™, biosimilars of Prolia® and Xgeva® respectively. Bosaya™ is approved for treating various forms of osteoporosis, while Aukelso™ is indicated for preventing skeletal-related events in cancer patients and treating giant cell tumor of bone. Both biosimilars have provisional interchangeability designation. The approval could significantly impact the U.S. healthcare market, where denosumab generated nearly $5 billion in sales. The biosimilars demonstrated comparable quality, safety, and efficacy to their reference products in clinical trials.
15Sept 25
Biocon Sets Sights on Generic Ozempic Market, Targeting Emerging Markets by End-2026
Biocon, an Indian biopharmaceutical company, announces plans to enter the generic Ozempic market. The company aims to launch in emerging markets by end of 2026 and in the US by early 2026. Biocon already sells Liraglutide API in UK and Europe. The global GLP-1 market is estimated to exceed $160 billion by 2034, with Semaglutide patents expiring in 2031. Biocon has developed processes to compete with Chinese API sources and expects its Bengaluru plant to generate revenues within 2-3 years.
11Sept 25
Biocon Expands Global Footprint with First U.S. Manufacturing Facility in New Jersey
Biocon Limited has opened its first FDA-approved formulations facility in Cranbury, New Jersey, marking a significant expansion into U.S. manufacturing. The company invested over $30 million in the state-of-the-art plant, which has an annual production capacity of 2 billion tablets. The facility, operated by Biocon Generics Inc, has already begun commercializing products. The inauguration was attended by New Jersey Governor Phil Murphy and Biocon Chairperson Kiran Mazumdar-Shaw. This strategic move aims to enhance Biocon's supply chain resilience and accelerate its global footprint expansion in the U.S. healthcare market.
05Sept 25
Biocon Biologics Secures $30 Million Investment from Tata Capital Growth Fund
Biocon Limited announced that Tata Capital Growth Fund will invest Rs 225 crore for a 0.85% stake in its subsidiary, Biocon Biologics. The deal values Biocon Biologics at an equity valuation of Rs 26,250 crore and an enterprise valuation of Rs 30,400 crore. Biocon will retain a 95.25% stake in the biosimilars unit. The funds will be used for general corporate purposes, including loan repayment. Biocon Biologics aims to serve 5 million patients and achieve $1 billion in revenue by FY22. The transaction is subject to standard approvals. Separately, Biocon's management will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 8, 2025, in New York City.
04Sept 25
USFDA Inspection at Biocon Biologics Facility Results in Form 483 with Five Procedural Observations
Biocon Biologics' facility in Bengaluru underwent a routine FDA inspection, resulting in a Form 483 with five procedural observations. The company stated these don't involve data integrity issues or systemic non-compliance. Biocon plans to submit a comprehensive Corrective and Preventive Action plan within the FDA's timeline and doesn't anticipate any impact on commercial product supply. The inspection covered drug substance manufacturing units, analytical QC laboratories, microbiology laboratories, and warehouses.
26Aug 25
Biocon Pharma Secures Tentative FDA Approval for Generic Sitagliptin Tablets
Biocon Pharma, a subsidiary of Biocon Limited, has received tentative FDA approval for its Abbreviated New Drug Application (ANDA) of Sitagliptin tablets, used to treat Type 2 diabetes. The approval covers 25 mg, 50 mg, and 100 mg dosage strengths. This development strengthens Biocon's portfolio of vertically integrated drug products and positions the company to compete in the U.S. generic drug market for diabetes treatments.
15Aug 25
Biocon's Kiran Mazumdar-Shaw Advocates for Regulatory Reforms in Pharma Sector
Kiran Mazumdar-Shaw, Executive Chairperson of Biocon and Biocon Biologics, responded to PM Modi's Independence Day speech, emphasizing the need for self-reliance and innovation in the pharmaceutical sector. She stressed the importance of regulatory reforms to accelerate drug development, highlighting that the current lengthy process deters investment in innovative molecules. Mazumdar-Shaw advocated for developing homegrown solutions over relying on overseas products, citing China as an example of how regulatory ecosystems can drive domestic innovation. She expressed optimism about the government's intention to implement reforms, starting with changes in the GST system, which could create momentum for broader reforms in the pharmaceutical sector.
14Aug 25
Biocon Reports 15% Revenue Growth in Q1, Raises INR 4,500 Crores Through QIP
Biocon Limited reported a 15% year-on-year growth in operating revenue for Q1, reaching INR 3,942 crores. Core EBITDA increased by 11% to INR 1,003 crores. Biosimilars segment revenue grew 18%, while CRDMO and Generics segments saw 11% and 6% growth respectively. The company completed a INR 4,500 crore QIP, received regulatory approvals for biosimilars, and expanded facilities. Management expects strong double-digit growth for the full year.
08Aug 25
Biocon Shareholders Approve Re-appointment of Key Directors at 47th AGM
Biocon Limited held its 47th Annual General Meeting on August 8, 2025, approving significant board re-appointments. Shareholders re-elected Prof. Ravi Rasendra Mazumdar as a Director and Ms. Naina Lal Kidwai as an Independent Director for a five-year term. The company reported strong financial performance with consolidated revenue of ₹3,942.00 crore, up 15% year-on-year. Executive Chairperson Kiran Mazumdar-Shaw highlighted strategic initiatives including capital investments, manufacturing capacity expansion, and R&D enhancement. Biocon's focus remains on accelerating global reach for essential medicines and driving sustainable growth.
08Aug 25
Biocon Reports Strong Q1 FY26 Growth: Revenue Up 15%, Biosimilars Lead Gains
Biocon Limited announced robust Q1 FY26 results with consolidated revenue reaching Rs 3,942.00 crore, up 15% year-on-year. EBITDA grew 19% to Rs 829.00 crore. Biosimilars segment led growth with 18% revenue increase. The company received FDA approval for Kirsty™, launched Yesafili™ in Canada, and raised Rs 4,500.00 crore through QIP. Management expressed confidence in continued growth across all segments.
04Aug 25
Biocon Shares Worth Rs. 60.87 Crores Traded in NSE Block Deal
Biocon Ltd. experienced a significant block trade on the NSE, involving 1,623,691 shares at Rs. 374.90 per share. The total transaction value amounted to Rs. 60.87 crores. This large-scale trade demonstrates substantial investor interest in the biopharmaceutical company's stock and could potentially impact short-term price movements.
23Jul 25
Biocon Biologics Expands Global Footprint with Nepexto Launch in Australia
Biocon Biologics, a subsidiary of Biocon Limited, has introduced Nepexto, a biosimilar to Enbrel (Etanercept), in the Australian market. This launch marks the company's entry into Australia's biosimilar landscape, offering a more affordable alternative for treating autoimmune disorders such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The move is expected to open new avenues for growth, enhance Biocon's global presence, and potentially contribute to revenue growth.
17Jul 25
Biocon Ltd. Sees Block Trade of 788,078 Shares Worth Rs. 31 Crores
A significant block trade of Biocon Ltd. shares occurred on the National Stock Exchange. Approximately 788,078 shares, valued at Rs. 31.00 crores, were traded at Rs. 393.30 per share. The transaction, involving a large volume of privately negotiated securities, could indicate shifts in institutional holdings or significant shareholder movements.
16Jul 25
Biocon's Kirsty™ Secures FDA Approval as First Interchangeable Rapid-Acting Insulin Aspart in US
Biocon Ltd's subsidiary, Biocon Biologics Ltd, has received FDA approval for Kirsty™ (Insulin Aspart-xjhz), the first interchangeable biosimilar to NovoLog® in the US. Kirsty™, a rapid-acting human insulin analog for diabetes treatment, will be available in prefilled pens and multiple-dose vials. The approval expands Biocon's biosimilar insulin portfolio, which includes Semglee®. With 38.4 million diabetics in the US, this approval aims to improve insulin accessibility and affordability. Analysts project annual sales of $80-100 million post-formulary addition for Kirsty™.
16Jul 25
Biocon Biologics Secures FDA Approval for Kirsty™, First Interchangeable Rapid-Acting Insulin Aspart in U.S.
Biocon Biologics, a Biocon Ltd subsidiary, has received FDA approval for Kirsty™ (Insulin Aspart-xjhz), the first interchangeable biosimilar to NovoLog® in the US. Kirsty™ is a rapid-acting insulin for diabetes management in adults and children, available in prefilled pens and vials. This approval expands Biocon's biosimilar insulin portfolio in the US market, where 38.40 million people have diabetes. The US Insulin Aspart market is valued at approximately $1.90 billion. Biocon Biologics, a global leader in biosimilars and insulin, serves over 5.80 million patients annually with 9.20 billion insulin doses globally.
07Jul 25
Biocon Biologics Secures UK Approval for Two Denosumab Biosimilars
Biocon Biologics, a Biocon Limited subsidiary, has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for two denosumab biosimilars, Vevzuo and Evfaxy. These biosimilars, designed to treat bone-related conditions, mark a significant milestone in the company's international expansion. The approval is expected to enhance Biocon Biologics' portfolio in the UK market, potentially increase accessibility to bone health treatments, and strengthen its position in the global biosimilars market.
03Jul 25
Biocon Biologics Secures European Commission Approval for Two Denosumab Biosimilars
Biocon Biologics, a subsidiary of Biocon Limited, has received European Commission approval for two denosumab biosimilars, Vevzuo and Evfraxy. Vevzuo is approved for preventing skeletal-related events in adults with advanced bone malignancies, while Evfraxy is authorized for treating osteoporosis and bone loss associated with long-term glucocorticoid therapy. This approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is expected to strengthen Biocon Biologics' position in the global biosimilars market.
02Jul 25
Biocon Sets Sights on Generic Versions of Popular Weight Loss Drugs
Biocon, an Indian biopharmaceutical company, announces plans to seek approval for generic versions of diabetes and weight loss drugs Ozempic and Wegovy. The company aims to enter the market as these drugs' patents expire next year. This move could potentially increase accessibility to these treatments through lower-cost alternatives and intensify market competition in the diabetes and weight loss medication sector.
30Jun 25
Biocon Biologics Boosts Insulin Supply in Malaysia, Treating Over 345,000 Patients
Biocon Biologics, a subsidiary of Biocon Ltd, has significantly increased its insulin supply to the Malaysian Health Ministry, providing over 100 million cartridges of recombinant human insulin. This expansion has enabled the treatment of more than 345,000 patients in Malaysia, showcasing the company's ability to meet substantial healthcare demands and strengthening its position in the Malaysian market.
27Jun 25
Biocon Biologics Secures Health Canada Approval for Yesafili, Eyes Global Launch
Biocon Biologics, a Biocon Limited subsidiary, has received Health Canada approval for Yesafili, its biosimilar version of Aflibercept. This approval is part of the company's global expansion strategy, with plans to launch the product worldwide starting July 2025. Yesafili is used to treat eye conditions such as age-related macular degeneration and diabetic macular edema.
26Jun 25
Biocon Invests $198.5 Million in Biocon Biologics Through Debenture Acquisition
Biocon has acquired 1,125 Optionally Convertible Debentures (OCDs) of its subsidiary, Biocon Biologics, for $198.50 million. This internal financial transaction could be aimed at strengthening the subsidiary's financial position, providing capital for expansion, or potentially increasing Biocon's stake in Biocon Biologics in the future. The move demonstrates Biocon's commitment to its biologics business and may signal confidence in Biocon Biologics' long-term prospects.
24Jun 25
Biocon Biologics Launches Patient Support Program in Malaysia for Cancer Treatment
Biocon Biologics, a subsidiary of Biocon, has partnered with the National Cancer Society of Malaysia to launch a patient support program. The initiative aims to enhance the affordability and accessibility of biosimilar medications for cancer patients in Malaysia. This strategic collaboration focuses on reducing the financial burden of cancer treatment and improving access to advanced biosimilar therapies. The program could potentially lead to expanded treatment options, improved patient outcomes, and economic relief for cancer patients.
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