Biosimilars: FDA Calls For Comment on Data Needed To Show a Product is “Interchangeable”; Estimates Time Burden of Biosimilar Applications to be Same As Traditional Biologic License Applications Read more
Biosimilars Update: FDA Staff Recommends Approval of First Biosimilar in U.S.; Agency Accepts Third Biosimilar Application For Review Read more
Biosimilars Update: FDA Releases “Purple Book”; Two Companies File Biosimilar Applications, Industry Responds to Draft Guidance Read more