On April 26, 2025, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Limited, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued positive opinions recommending approval for its denosumab biosimilar candidates: Vevzuo® and Denosumab BBL (brand name pending approval), for distinct therapeutic indications related to bone health, specifically osteoporosis.

This significant milestone is based on a thorough review of comprehensive data packages, which included the results of various clinical studies. These studies demonstrated that the biosimilars were comparable to the reference product, Prolia®, in terms of key parameters such as pharmacokinetics, safety, efficacy, and immunogenicity profiles.

The CHMP Positive Opinions:

The CHMP, which is responsible for recommending marketing authorization for medicines in the European Union, issued these positive opinions following a rigorous evaluation process. The recommendation will now be reviewed by the European Commission, which is expected to make the final decision regarding marketing authorisation for the biosimilars.

These biosimilars will be indicated for bone health treatments, specifically targeting conditions like osteoporosis, providing more affordable treatment options to patients.

• Vevzuo® and Denosumab BBL are the two candidates under consideration for approval in Europe.

• The positive opinions reflect the biosimilars' efficacy and safety, showing promising potential to improve the therapeutic landscape for patients with osteoporosis.

Key Clinical Trials and Data:

The clinical studies conducted on the denosumab biosimilars demonstrated their comparability to the reference product in terms of safety, efficacy, and immunogenicity profiles. Notably, the trials that formed the basis for the approval process included:

• A Phase 3 randomized, double-blind study, which showed that the biosimilar Bmab-1000 was equivalent to Prolia in terms of pharmacodynamics, safety, and immunogenicity in postmenopausal women with osteoporosis. This was a key study presented at the ACR Congress 2024.

• The DEVOTE study, also conducted in postmenopausal women with osteoporosis, demonstrated that Bmab-1000 was equivalent to the reference product in terms of both efficacy and safety, with the study results presented at WCO-IEF-ESCEO 2025.

Awaiting European Commission Approval:

While the CHMP's positive opinion is a significant achievement, marketing authorisation for Vevzuo® and Denosumab BBL is still pending approval from the European Commission. If approved, detailed information about the indications, usage, and regulatory specifics will be included in the Summary of Product Characteristics (SmPCs) and the European Public Assessment Reports (EPARs). These documents will be available in all official European Union languages.

Until the European Commission grants final approval, these products cannot be marketed or used within the European Union.

Biocon Biologics’ Commitment to Biosimilars:

Biocon Biologics Ltd, a global leader in the biosimilars sector, has positioned itself at the forefront of affordable healthcare solutions. The approval of Vevzuo® and Denosumab BBL will further strengthen the company’s portfolio in the biopharmaceutical space, especially in bone health treatments.

The positive CHMP opinions mark a pivotal moment in Biocon’s journey towards providing high-quality, cost-effective biosimilars to patients across the globe. The company’s commitment to innovative biologics ensures a positive impact on both healthcare access and overall market dynamics.

Conclusion:

The positive CHMP opinions are a promising step forward for Biocon Biologics and its biosimilar candidates. These developments bring hope to the osteoporosis community in Europe, offering affordable treatment alternatives to patients. The final approval from the European Commission will further solidify Biocon’s position in the competitive biosimilar market, especially in the European Union.

Investors and stakeholders are encouraged to monitor the European Commission's review, as it could represent a key milestone for the company’s global expansion in the biosimilars and biopharmaceutical industry.

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