FDA ‘Encouraging Evergreening’ With Strength Definition – Boehringer Ingelheim
Minor Concentration Changes Being Used As ‘Anticompetitive Tactic’
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.”
