Pharmacy and Wellness Review
Abstract
Biologic products are widely used in the treatment of various disease states, including rheumatoid arthritis, inflammatory bowel disease, cancers, and genetic diseases. These products are derived from proteins and genes produced by living organisms and are subsequently used to treat specific disease states. Due to the complexity of biological products, the costs of research and production are high. Currently, the United States approval pathway requires extensive testing for biologics to be designated as biosimilars, meaning there are no clinically meaningful differences in safety or purity of their active components. These required tests can be redundant, as biosimilars are developed using the same reference product, unnecessarily increasing development costs and delaying patient access. As a result, the Food and Drug Administration (FDA) has decided to follow the European Medicines Agency (EMA) by progressively adopting drug function and chemical property tests in place of additional clinical efficacy studies (CESs). Waiving CESs can make the biosimilar approval process more efficient, ethical, and affordable while improving patient access without compromising safety or efficacy. The risks and benefits of waiving CESs need to be carefully considered, and patients and providers need to be appropriately informed of biosimilar interchangeability. By increasing prescribers’ familiarity with biosimilars, patients can be treated more promptly and receive higher-quality care at a more affordable cost.
Included in
Biological Factors Commons, Food and Drug Law Commons, Medicinal and Pharmaceutical Chemistry Commons, Pharmaceutical Preparations Commons, Pharmaceutics and Drug Design Commons, Pharmacoeconomics and Pharmaceutical Economics Commons, Pharmacy Administration, Policy and Regulation Commons