Zydus Lifesciences has entered into a strategic partnership with Swiss biopharmaceutical company Bioeq AG for the commercialisation of NUFYMCO, an FDA-approved interchangeable biosimilar to Lucentis (Ranibizumab) in the US market. The collaboration marks a significant expansion of Zydus's US biosimilar business portfolio, with the US biosimilar Ranibizumab market worth $210.00 million.

Partnership Details and FDA Approval

The strategic partnership involves Zydus Lifesciences Global FZE, a wholly-owned subsidiary of Zydus based in the United Arab Emirates, collaborating with Bioeq for the licensing, supply and commercialisation of NUFYMCO. The Biologics License Application (BLA) for NUFYMCO received approval from the US Food and Drug Administration (USFDA) on December 18, 2025.

Role Distribution and Responsibilities

Under the terms of the agreement, both companies will leverage their respective strengths to ensure successful market penetration. Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will handle the commercialisation of NUFYMCO in the US market.

This partnership follows Zydus's recent collaboration with Formycon AG for a biosimilar of Keytruda (Pembrolizumab), demonstrating the company's strategic focus on expanding its US biosimilar business through partnerships with established European biopharmaceutical companies.

Market Opportunity and Strategic Vision

The total addressable market opportunity for biosimilar Ranibizumab in the US is approximately $210.00 million as per IQVIA MAT September 2025. Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, expressed enthusiasm about the collaboration, stating that the partnership will leverage combined expertise and resources to accelerate organisational growth while ensuring maximum value to patients through expanded access to affordable ophthalmology care.

Dr. Thiemo Schreiber, Vice President Commercial at Bioeq, highlighted the regulatory approval significance and emphasised how the partnership will leverage Zydus's extensive distribution network and strong sales and marketing capabilities across the US to broaden treatment options for patients.

Company Profiles

Zydus Lifesciences Limited operates as an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 29,000 people worldwide, including 1,500 scientists engaged in R&D.

Bioeq AG, established in 2014, is a Swiss biopharmaceutical joint venture between Polpharma Biologics Group and Formycon AG. The company specialises in the development, licensing, and commercialisation of biosimilars for highly regulated markets worldwide, focusing on creating cost-effective alternatives to leading biologics.

Zydus Lifesciences has secured a significant regulatory milestone with the High Court granting permission to manufacture semaglutide, a key medication used in diabetes treatment and weight management. The court order also authorizes the pharmaceutical company to export the drug to specific international markets.

Regulatory Approval Details

The High Court's decision enables Zydus Lifesciences to enter the manufacturing of semaglutide, which represents an important addition to the company's pharmaceutical portfolio. The approval encompasses both domestic manufacturing rights and export authorization to certain nations, positioning the company to serve select international markets.

Strategic Implications

This regulatory clearance positions Zydus Lifesciences to participate in the growing diabetes care market through semaglutide production. The export authorization particularly enhances the company's potential to expand its international pharmaceutical business operations in the diabetes and metabolic health treatment segment.

The court's permission marks a notable development for Zydus Lifesciences in strengthening its presence in the specialized therapeutic area of diabetes care and weight management solutions.