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Interchangeable Exclusivity: Pfizer To Rival Boehringer On Humira Biosimilar After US FDA Decision

 
• By Dave Wallace

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.

Hourglass timer dissolving, end of time period concept
The FDA decision has ended Boehringer’s exclusivity period • Source: Shutterstock

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...

Key Takeaways

  • US FDA has approved Pfizer’s Abrilada (adalimumab-afzb) as the second interchangeable biosimilar to Humira. Launch is expected this month.

  • First interchangeable biosimilars are...

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