ALFA Filings
Every announcement, straight from the exchange
Reference market data from a third-party provider, updated daily. Not a valuation or a recommendation.
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4 announcements with these filters
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.