FDA issued a complete response letter for Mylan's application for a biosimilar version of Amgen's Neulasta. However, Mylan said the CRL does not change its US launch expectations, targeted for late 2018 or early 2019.
Mylan NV is the fourth company to receive a complete response letter from FDA related to a biosimilar version of Amgen Inc.'s Neulasta (pegfilgrastim), highlighting the challenges with bringing a copy of the pegylated neutropenia drug to market.
Mylan and its biosimilar development partner Biocon Ltd. announced the CRL Oct. 10 and said it was related to a...
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The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
