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FDA Offers Insights On Second Interchangeable Adalimumab

Agency Sheds Light On Decision To Deem A Second Humira Biosimilar Interchangeable

 
• By Dave Wallace

The FDA recently approved a second US Humira biosimilar, from Pfizer, as interchangeable – just a few months after the launch of Boehringer Ingelheim’s interchangeable Cyltezo – despite first interchangeable biosimilars benefiting from a year of exclusivity. Now, the agency has shed further light on the decision in response to Generics Bulletin queries.

Spotlights
The FDA has shed light on its recent interchangeability decision

In the wake of a US Food and Drug Administration decision that saw a second US Humira (adalimumab) biosimilar approved as interchangeable just a few months after the launch of the first interchangeable adalimumab – despite the year of exclusivity that is meant to be the prize for first interchangeable biosimilars – the FDA has offered further insights into the decision.

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