Sandoz: approval of Pyzchiva in Europe

(CercleFinance.com) - Sandoz announces that the European Commission has granted marketing authorization (MA) for Pyzchiva, developed and registered by Samsung Bioepis, making it one of the first ustekinumab biosimilars approved in Europe.


This approval as a biologic treatment in gastroenterology, dermatology and rheumatology, was based on a program confirming correspondence with the reference drug in terms of safety, efficacy and quality.

Under the terms of its September agreement with Samsung Bioepis, the Swiss generics and biosimilars group has the right to market Pyzchiva in the USA, Canada, the European Economic Area, Switzerland and the UK.


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