US FDA Outlines Biosimilar First Interchangeability Policy … In A Memo
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.
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While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.
FDA decision ends Boehringer Ingelheim’s exclusivity for interchangeable biosimilar of Humira after just a few months. Pfizer reveals pricing and launch information for its Abrilada version of adalimumab.
An FDA decision around the timing of first interchangeable biosimilar exclusivity has brought to an end Boehringer Ingelheim’s time on the market with a unique interchangeable Humira rival, with the agency also granting interchangeability for Pfizer’s Abrilada version of adalimumab.