As US FDA sees dip in application development, experts offer contrasting assessments about future of biosimilars at AAM's GRx Biosims conference.
The US FDA saw the number of biosimilar development programs in the agency's Biosimilar Biological Product Development (BPD) program take a dip in the later months of 2017. But are these few months of data indicative of a new downward trend of investment in alternatives to originator products?
It is likely too soon to draw any definitive conclusions. But experts nevertheless offered contrasting opinions about whether biosimilars will...
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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.
