FDA’s Latest Deemed Biologics List Raises Exclusivity Issues For Sanofi

By Beth Wang / January 16, 2020 at 11:10 AM
Two Sanofi insulin products will lose exclusivity protections as a result of FDA’s updated list of drugs that will be considered biologics in March, a shift that Sanofi previously argued would violate the Fifth Amendment. The update, released Wednesday (Jan. 15), includes lixisenatide, the active ingredient in two Sanofi insulin products that will lose their “drug” status and the associated exclusivity protections. The updated list includes four new drugs, three of which were added because of congressional changes to the...


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