Company says requirement that distinguishable suffixes be added to existing biologics creates the kind of economic burden targeted in President Trump’s executive order aimed at undoing the Affordable Care Act, which also established the biosimilar pathway.
The US FDA’s plan to require that sponsors of currently marketed biologics add a distinguishable nonproprietary name suffix is the type of “unnecessary regulatory burden” targeted by the Trump Administration, AbbVie Inc. believes.
In Feb. 13 comments, AbbVie said that Office of Management and Budget (OMB) approval of FDA’s proposed information...
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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.
