Latest From Biocon Ltd.
Appropriations report directs the US FDA to offer the faster assessment and allow reliance on prior data submitted for applications caught in the transition from drug to biologic regulation.
Biocon has joined the march of Indian firms into China, tying up with Chinese firm CMS to sell three generic formulations in the world’s second-largest drug market.
Natco has sprung a challenge to Novartis’ vildagliptin patent in India, months before its expiry. The Indian firm will hold back further release of its product on the market amid legal action and it remains to be seen if Novartis will pursue damages.
Court grants request to substitute Accord BioPharma for Apotex in Amgen infringement suit. Apotex says it has no plans to exit the biosimilar business.
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