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 FDA to create an educational website with information covering key statutory and regulatory terms.
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 US law firm, Haynes and Boone, spoke to BioPharma-Reporter about what impact this legislation will have on the US biosimilars market.
