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FDA ‘Encouraging Evergreening’ With Strength Definition – Boehringer Ingelheim

Minor Concentration Changes Being Used As ‘Anticompetitive Tactic’

 
• By Dean Rudge
  
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With a biosimilar to Humira (adalimumab) in the wings, Boehringer Ingelheim is calling on the US Food and Drug Administration to amend its current interpretation of the term “strength” as applied to parenteral solutions, arguing it is “invalid as a matter of both law and policy.”

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The FDA's definition of strength for injectable biologics is "arbitrary and capricious," Boehringer insists. • Source: Shutterstock

The US Food and Drug Administration’s current interpretation of the term “strength” in section 351(k) of the Public Health Service Act as applied to parenteral solutions is encouraging brand sponsors to use minor concentration changes as an anticompetitive tactic to stymie biosimilar and interchangeable biological products, according to a citizen petition filed by Boehringer Ingelheim.

The German firm, which has developed a biosimilar to AbbVie’s Humira (adalimumab) under the name Cyltezo (adalimumab-adbm), has called on...

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