Biosimilars gaining traction in the USA

A feature on recent market activity in the biosimilar sector.

According to market research, biosimilars are at a major inflection point, as the US Congress introduces new drug pricing legislation and new biologic medicines enter the market. It is clear that they continue to play a crucial role in driving down healthcare costs in the USA.

In January 2023, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Amendments (BsUFA) III Regulatory Science Pilot Program: Research Roadmap, which aims to identify knowledge gaps, direct research and improve the efficiency of biosimilar product development. Although further work is needed to increase patient access to biosimilars in the USA, some products such as insulin and monoclonal antibodies to treat cancer are gaining traction as healthcare professionals and patients accept they are safe, effective, and affordable alternatives to branded biologics.