Responding to questions seeking clarifications over a statement on the scientific rationale supporting the interchangeability of biosimilars in the EU, the EMA has issued a supplementary Q&A document to address issues around multiple switches, complexity of molecular structure and national switching policies.
Questions over switching between multiple biosimilars and biologics, the relevance of complexity of biosimilar molecular structure to biosimilar switching, and national European switching policies have all been addressed in a fresh Q&A document published by the European Medicines Agency.
The Q&A follows up on the statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU that...
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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.
