Biocon Biologics Ltd. (BBL), a subsidiary of Biocon Ltd., has achieved a significant milestone in its mission to expand access to critical biologic therapies. The U.S. Food and Drug Administration (FDA) has granted approval for two of the company's biosimilar products, Bosaya™ and Aukelso™, both denosumab biosimilars.

FDA Approval Details

Bosaya™ (denosumab-kyqq), a biosimilar of Prolia®, is a 60 mg/mL injection for subcutaneous use in a single-dose prefilled syringe. Aukelso™ (denosumab-kyqq), a biosimilar of Xgeva®, is a 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Both products have received provisional interchangeability designation from the FDA.

Therapeutic Applications

Bosaya™

Bosaya™ is approved for treating osteoporosis in various patient populations, including:

• Postmenopausal women at high risk of fracture
• Men with osteoporosis at high risk of fracture
• Patients with glucocorticoid-induced osteoporosis
• Men receiving androgen deprivation therapy for nonmetastatic prostate cancer
• Women receiving adjuvant aromatase inhibitor therapy for breast cancer

Aukelso™

Aukelso™ is indicated for:

• Preventing skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors
• Treating adults and skeletally mature adolescents with giant cell tumor of bone
• Managing hypercalcemia of malignancy refractory to bisphosphonate therapy

Market Impact

The approval of these biosimilars could have a significant impact on the U.S. healthcare market. According to IQVIA data, denosumab generated nearly $5.00 billion in U.S. sales, with Prolia® accounting for $3.30 billion and Xgeva® for $1.60 billion.

Company Perspective

Shreehas Tambe, CEO & Managing Director of Biocon Biologics, expressed pride in offering more affordable treatment options for patients with osteoporosis and expanding the company's oncology care portfolio. He stated, "This achievement underscores our scientific and regulatory capabilities and reinforces our commitment to delivering high-quality biosimilars that support sustainable healthcare systems and improve patient outcomes."

Clinical Data and Safety Information

Both biosimilars demonstrated comparable quality, safety, and efficacy to their reference products in clinical trials. Bosaya™ is approved with the same Risk Evaluation and Mitigation Strategy (REMS) plan as Prolia® to inform healthcare providers and patients about the risks of severe hypocalcemia in patients with advanced chronic kidney disease.

Epidemiology and Market Need

Osteoporosis affects approximately 10 million adults over age 50 in the U.S., with another 44 million at risk due to low bone density. The approval of Bosaya™ could potentially increase access to treatment for this significant patient population.

Bone metastases, which Aukelso™ is approved to treat, affect more than 330,000 patients annually in the United States, highlighting the importance of accessible treatment options in oncology care.

The approval of Bosaya™ and Aukelso™ marks another step forward in Biocon Biologics' mission to expand access to critical biologic therapies and improve patient outcomes through high-quality, affordable biosimilars.

Biocon , a leading Indian biopharmaceutical company, has announced ambitious plans to enter the lucrative market for generic versions of Ozempic, a popular diabetes and weight loss medication. The company is gearing up to file applications for launching these generic versions in multiple markets during the current quarter, signaling a significant move in the competitive pharmaceutical landscape.

Global Expansion Strategy

CEO Siddharth Mittal has outlined a strategic timeline for Biocon's entry into this high-value market segment:

• Emerging Markets: Biocon aims to introduce its generic Ozempic in emerging markets by the end of 2026.
• US Market: The company has set its sights on an early 2026 launch in the United States, a key market for pharmaceuticals.

Existing Presence in GLP-1 Market

Biocon is not new to the GLP-1 (Glucagon-Like Peptide-1) drug market. The company already has a foothold in this space:

• Currently sells Liraglutide API (Active Pharmaceutical Ingredient) for GLP-1 drugs in the UK and Europe.
• This existing presence provides Biocon with valuable experience and market insights.

Patent Landscape and Market Opportunity

The timing of Biocon's strategy aligns with the patent expiration of Semaglutide, the active ingredient in Ozempic:

• Semaglutide patents are set to expire in 2031 in both the US and Europe.
• The global GLP-1 market opportunity is estimated to exceed $160.00 billion by 2034.
• Biocon joins a competitive field of at least 15 companies vying for a share of this substantial market.

Manufacturing and Competition

To position itself competitively in the market, Biocon has taken several strategic steps:

• Developed processes to compete with Chinese API sources, a major player in the pharmaceutical ingredient market.
• The company's Bengaluru plant is expected to start generating revenues within 2-3 years, potentially boosting its manufacturing capabilities for these new products.

Industry Implications

Biocon's entry into the generic Ozempic market could have significant implications for both patients and the pharmaceutical industry:

• Increased competition may lead to more affordable options for diabetes and weight management treatments.
• The move highlights the growing importance of the GLP-1 drug class in the global pharmaceutical market.

As Biocon prepares to file its applications this quarter, the pharmaceutical industry will be watching closely to see how this Indian biopharmaceutical giant fares in the increasingly competitive GLP-1 market. The company's success could potentially reshape access to these important medications in emerging markets and beyond.