New biosimilar Type 2a meeting will facilitate faster development, stakeholders said, but one representative also warned that the inspection backlog must be eliminated in order for the US FDA to meet the new user fee program commitments.
Biosimilar sponsors like the new user fee agreement because of its potential to reduce the number of necessary formal meeting requests and by extension speed development.
BsUFA III will create a new meeting type allowing sponsors to schedule a discussion with the US Food and Drug Administration sooner and receive answers to a limited number of questions. Cory Wohlbach, Teva Pharmaceutical Industries Ltd. global VP of biosimilar regulatory affairs, said 2 November during a public meeting on the
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.
An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.
