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White Paper

Generics and Biosimilars: Ensuring Quality from Beginning to End

Introduction

Manufacturers of generics and biosimilars must adhere to stringent quality, safety, and efficacy requirements during drug development; however, there are key differences between the two. “Generic products must demonstrate bioequivalence to the brand name drug whereas biosimilars must show biosimilarity,” said Dr. Amiji. “Generics must be identical in chemical composition to the innovator while biosimilars, which are far more complex, must show that they are highly similar.”