Amgen: Common Biosimilar, Reference Product Names Would Violate Statute

The generic drug industry's comparison equating biologic post-approval manufacturing changes to having common names for biosimilars and their reference product is “overly simplistic and irrelevant,” Amgen recently said countering several arguments against a distinguishable naming scheme. Amgen weighed in on the controversial debate in response to two citizen petitions from the Generic Pharmaceutical Association and Novartis, and said common names would raise “significant legal issues.” In the 89-page submission to FDA, Amgen makes its case against arguments that National Drug...