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US FDA Outlines Biosimilar First Interchangeability Policy … In A Memo

 
• By Derrick Gingery

Stakeholders may be irked that the agency chose to release a memo on its interpretation of the first interchangeable exclusivity law before issuing formal guidance.

Humira 40mg
The memo on Humira biosimilars reveals some interchangeable exclusivity policies but there is more unpacking to do • Source: Shutterstock

Releasing a memo on a specific case may not be the most effective way to inform industry, but the US Food and Drug Administration’s views on first interchangeable exclusivity are finally available in its resolution of the issue for Boehringer Ingelheim GmbH’s Cyltezo, a biosimilar of AbbVie Inc.’s Humira.

The 18-page memo is only intended to apply to the situation involving Cyltezo and Pfizer Inc.’s Abrilada, a...

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