Tentative-Style Approvals Coming For US Biosimilars?

06 Jul 2016

• By Donna Young

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.

If a ruling by a three-judge panel from the US Court of Appeals for the Federal Circuit stands and its regimen is adopted by the FDA – with encouragement from companies – the agency could be doling out tentative-style approvals for biosimilar medicines, letting their manufacturers know six months ahead of market entrance that their products have been licensed.

That's the apparent remedy the court is suggesting in its latest interpretation of the notice of commercial marketing (NCM) provision of the Biologics Price Competition and Innovation Act (BPCIA) –...

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