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Boehringer Secures FDA Approval For High-Concentration Cyltezo – But Without Interchangeability

The Formulation Did Not Receive The Designation Despite Meeting Requirements

 
• By Adam Zamecnik

Despite meeting the FDA’s requirements, Boehringer’s higher-concentration formulation of its Cyltezo rival to Humira has yet to receive the status, putting it at odds in a landscape that now has further options with the designation – including Alvotech that still enjoys exclusivity for its own interchangeable 100mg/ml adalimumab.

Boehringer Ingelheim sign
• Source: Shutterstock

The US Food and Drug Administration has approved Boehringer Ingelheim’s higher-concentration formulation of its Humira (adalimumab) biosimilar Cyltezo – but without granting it a coveted interchangeability designation, in an increasingly heated market.

While the company’s previously approved lower-concentration Cyltezo formulation was the first Humira biosimilar to receive the designation of interchangeability, the...

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