A US Food and Drug Administration decision around the timing of exclusivity for first interchangeable biosimilars has resulted in Pfizer being awarded an interchangeability designation for its Humira (adalimumab) rival, barely three months after the first interchangeable biosimilar from Boehringer Ingelheim hit the market.
Biosimilars designated as interchangeable in the US – meaning they can benefit from pharmacy-level substitution, subject to state law – can expect to enjoy a year of exclusivity for their interchangeability designation if they are
Key Takeaways
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US FDA has approved Pfizer’s Abrilada (adalimumab-afzb) as the second interchangeable biosimilar to Humira. Launch is expected this month.
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First interchangeable biosimilars are meant to benefit from a year of interchangeable exclusivity – but Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) has only been on the market since July
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