Regulatory change could improve biosimilar access in the US

Tiffany E Jiang , Reshma Ramachandran , and Joshua J Skydel argue that US requirements for interchangeability are not supported by evidence and hamper use of biosimilars Biological medicines (biologics) such as monoclonal antibodies have improved the treatment of numerous cancers, autoimmune diseases, and other conditions. They provide targeted treatment that enables patients to control their disease and lead healthier lives. Biologics are also among the most expensive available medications, accounting for almost one half of US drug spending in 2023 despite representing just 2% of prescriptions.1 Biosimilar products can lower prices and expand access to treatment, much like generic versions of small molecule drugs (box 1). However, whereas generic drugs are readily accepted as alternatives to branded products, biosimilars face challenges that have so far prevented them becoming widely used, especially in the US. Proposed changes to the Food and Drug Administration guidance could relax requirements and improve access to lower cost versions of these transformative therapies, but further changes are needed to maximise the benefits. Box 1 ### Key definitionsRETURN TO TEXT