ABSTRACT
INTRODUCTION Biosimilar drug products are recombinant, cell-derived protein products whose safety, identity, purity, impurities, potency, and quality can be determined, monitored, and controlled. These products are comparable in quality, safety, and efficacy to their corresponding innovative biotechnology-derived product(s) (brand product) and are distributed after patent expiry of the brand. These products are also known as “biological generics,” “generic biologics,” and “follow-on protein products.” As with chemical generics, biosimilars adhere to the same manufacturing standards and controls as the innovator. From a manufacture and quality perspective, approval of biosimilars is based on comprehensive chemistry, manufacturing, and controls data and information and review by regulatory authorities to include the Food and Drug Administration (1). Although manufacturing standards and quality of biosimilars are no different than those of brand products, biotechnology-derived drugs, in general, are different in many ways from chemically synthesized drugs.
