Biologics legislation heads to Biden's desk for signature.

As the need for more affordable biologic drugs continues to rise, two new bills related to biosimilars have been passed by Congress and now heading to President Biden for approval. (1) The first bill is the Advancing Education on Biosimilars Act and the second is Ensuring Innovation Act. Both bills await the President’s signature.

Advancing Education on Biosimilars Act would require the FDA to create a website targeted at healthcare providers, with a goal of increasing provider education about the safety, regulation, and effectiveness of these biologics and biosimilars. This information will be provided and updated on an ongoing basis based on new data. Educating providers about biologic/biosimilar has the potential to improve utilization of more affordable alternatives that have been shown equally effective.

The Ensuring Innovation Act would address challenges related to patent protections on drugs that are not described as true innovations. The objective of this law is to limit the impact of patent protection on biosimilar production/adoption and increase competition.

If signed into law, these bills have the potential to increase biosimilar drug competition and will likely cause changes in the market.