Safety and efficacy of biosimilar epoetins

8224 Background: Patents of innovator biopharmaceutical products, such as epoetin, are starting to expire allowing biosimilar versions of these products to eventually enter European and American markets. Generic drugs typically gain market approval via an abridged procedure demonstrating physicochemical similarity and bioequivalence. This concept cannot be applied to biopharmaceuticals because current analytical methods are inadequate to fully characterize these complex proteins. Ambiguous requirements for biosimilar products to gain approval for these markets have some manufacturers of biosimilar epoetins planning large, lengthy Phase III trials similar to those of an innovator product, while others expect to gain approval for all indications with a small study in Chronic Renal Failure (CRF) patients. This study compared biosimilar epoetin products to epoetin alfa and evaluated the quality and rigor of clinical studies performed with these products. Methods: Epoetin preparations marketed outside western ...