At House hearing, FDA and AAM highlight logistical challenges of legislation's six-month ANDA review goal and potential to put GDUFA II agreement at risk.
FDA and industry have serious concerns with a proposed six-month priority review pathway for generic drugs offered in recent legislation, arguing it may not actually get generics to market faster.
Both industry and agency agree with the bill's ultimate goal, pushing more generic competition to the market faster
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
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.
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
