Affordable Prescriptions for Patients Act Advances in Senate to Foster Generic Drug Competition

The U.S. Senate has approved a bill aimed at facilitating the entry of biosimilars and other generic drugs into the U.S. market by preventing drug manufacturers from creating "patent thickets" that impede competition.

Known as the Affordable Prescriptions for Patients Act, the legislation, sponsored by Senators John Cornyn (R-TX) and Richard Blumenthal (D-CT), now moves to the U.S. House for consideration.

The bill seeks to curb branded drugmakers from using multiple patents to block generic competition by limiting the number of patents that can be contested. Currently, there is no restriction on the number of patents drugmakers can assert during patent dispute resolution.

According to a statement from Cornyn’s office, the bill aims to prevent biologics manufacturers from manipulating the system to increase patent assertions, while maintaining the patent system's role in fostering innovation for new biologic treatments.

Co-sponsored by Senators Dick Durbin, Ted Cruz, Amy Klobuchar, Chuck Grassley, Peter Welch, Mike Braun, and Lisa Murkowski, the bill is seen as promoting competition and reducing prices for patients without stifling innovation.

Cornyn urged the House to swiftly pass the legislation, emphasizing its potential to promote competition and lower drug prices, while Blumenthal highlighted its role in protecting competition from abuses of the patent system by pharmaceutical companies.

Key players in the generic drug market include Teva, Dr. Reddy’s, Viatris, Sandoz, Amneal, and Amphastar. CVS Health has also expanded into the biosimilars market through its Cordavis unit.