ALFA Filings
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Every Biocon business update announcement on NSE and BSE, newest first, each with its own page.
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Biocon signed a licence agreement with Janssen to commercialise biosimilar Yesintek in nine more markets, including Australia, Brazil and China. No deal value is disclosed.
Biocon's Pertuzumab biosimilar received a positive CHMP opinion from the EMA, marking a milestone in its European regulatory path. Final European Commission approval is pending.
Biocon's US subsidiary received U.S. FDA approval for the Yesintek® prefilled autoinjector. This supplemental approval enhances the company's immunology portfolio.
Biocon announced the publication of Phase III clinical data supporting the effectiveness of its biosimilar Yesafili™. The data reinforces clinical equivalence ahead of its US launch.
Biocon Limited announced that the U.S. FDA completed a Pre-License Inspection at its Bengaluru biosimilars site. The inspection concluded with five procedural observations. The company plans to submit a corrective action plan and does not expect any impact on data integrity or quality oversight.