The complexities of biosimilars and the regulatory approval process

Abstract

Created via the Biologics Price Competition and Innovation Act, the biosimilar class of drugs was conceived as an opportunity to introduce competition for commonly used biologics following loss of patent protection and market exclusivity, similar to the generic paradigm that has helped sustain access and innovation for more than 3 decades. The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without any clinically meaningful differences in safety, purity, and potency. Given the concerns about increasing healthcare costs and this new opportunity to reduce the expense associated with biologics, including many commonly used oncology medications, the use of biosimilars will likely increase as numerous stakeholders, including managed care organizations, begin to implement policies to encourage adoption. As biosimilars are a relatively new class of drugs, clinical, scientific, and regulatory aspects continue to evolve and improve. Understanding those various aspects can improve clinician acceptance and advance the science of biologics and biosimilars. In this report, various factors are addressed to improve the knowledge of biosimilars, including clinical, manufacturing, and cost considerations.