Independent pharmacies could see more affordable treatment options and greater competition in the biologics market if two bipartisan bills continue to advance through Congress.
(July 2026) In June, the Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously approved the Biosimilar Red Tape Elimination Act, sending it to the full Senate for consideration. The committee also advanced the Medication Affordability and Patent Integrity Act, which aims to reduce patent practices that can delay lower-cost alternatives from reaching the market.
For independent pharmacies, both bills have the potential to improve patient access while creating a more competitive prescription drug marketplace.
The Biosimilar Red Tape Elimination Act would eliminate the FDA’s separate “interchangeable” designation for biosimilars. Although the FDA has repeatedly stated that approved biosimilars are just as safe and effective as their reference biologics, manufacturers currently must complete additional studies before a product can receive an interchangeability rating for pharmacy substitution.
Supporters say the extra requirement creates unnecessary confusion for providers and patients while slowing competition. Removing that distinction could simplify the approval process, encourage more manufacturers to enter the market and increase the availability of lower-cost biosimilars.
The opportunity is significant. Since the first biosimilar entered the U.S. market in 2015, these products have generated more than $56 billion in healthcare savings. Industry experts believe eliminating unnecessary regulatory barriers could accelerate those savings while expanding treatment options for patients.
The second bill, the Medication Affordability and Patent Integrity Act, addresses another challenge: delaying competition through overlapping or serial patents. The legislation would strengthen coordination between the FDA and the U.S. Patent and Trademark Office, making it more difficult to use patent strategies that keep generic and biosimilar competitors off the market longer than intended.
More timely competition benefits everyone in the pharmacy supply chain. Earlier availability of lower-cost alternatives can help reduce acquisition costs, improve patient affordability and give independent pharmacies additional options when managing therapy.
One proposal that did not move forward was the Ensuring Timely Access to Generics Act, which would have strengthened oversight of FDA citizen petitions that some critics say are used to delay generic approvals.
While none of these bills have become law, they reflect continued bipartisan interest in increasing competition and addressing prescription drug costs. AAP will continue monitoring these proposals and keep Members informed about legislative changes that could affect purchasing strategies, patient access and the future of independent pharmacy.