Tentative-Style Approvals Coming For US Biosimilars?

A three-judge panel from the US Court of Appeals for the Federal Circuit on July 5 ruled that the 180-day notice of commercial marketing applies to all biosimilar applicants, giving a win to Amgen over Apotex. But in its latest interpretation of the US biosimilars law, the court appears to suggest the FDA needs to establish a tentative-style approval approach for those products, similar to what's employed for generic drugs.