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Here is an excerpt:
There is much work to be done in the United States to increase usage of biosimilars, stimulate competition and reduce prices for patients.
The Advancing Education on Biosimilars Act, just signed into law, is meant to improve confidence in biosimilars and lead to increased use and savings by requiring the Department of Health and Human Services (DHHS) to create an educational website that will help counter misinformation about the safety and efficacy profile of biosimilars. Mainly, the website will provide information regarding key scientific and regulatory terms and also put on healthcare provider and patient education programs.
The Ensuring Innovation Act would impose more restrictions on which biologic drugs and generic drugs qualify for product exclusivity protections by replacing the term “active ingredient” with “active moiety” when defining a new chemical entity.
Roger Kuan, a partner at U.S. law firm Haynes and Boone, spoke to BioPharma-Reporter about what impact this legislation will have on the US biosimilars market.