A bipartisan bill sponsored on Sept. 19 by U.S. Rep. August Pfluger (R-TX) aims to improve patient access to lower-cost prescription medications and increase competition in the biological drug market.
The Biosimilar Red Tape Elimination Act, H.R. 5526, which is cosponsored by U.S. Rep. Greg Landsman (D-OH), would automatically deem “biosimilar” drugs as interchangeable with their name-brand counterparts upon approval by the Food and Drug Administration (FDA).
“Our healthcare system is unfortunately marked by skyrocketing costs, especially when it comes to prescription drugs. For far too long, unnecessary barriers and outdated FDA requirements have prevented Americans from accessing a less expensive, generic version of their medication,” Rep. Pfluger said. “Our legislation is a simple, common-sense step we can take to ensure Texans keep more of their hard-earned money by eliminating this burdensome red tape that disincentivizes competition and drives prescription drug prices up for all patients.”
If enacted, H.R. 5526 would amend the federal code to state that all biosimilars, upon approval, shall be deemed interchangeable. The bill still uses the term “interchangeable” because states have crafted their own laws around interchangeability. Retaining that word would provide for minimal disruption to current biosimilar distribution, according to a bill summary provided by the congressman’s office.
Additionally, H.R. 5526 would strike the current requirement in the code that has been used to justify switching studies; create a cool-down period for certain biologics that were already granted exclusive interchangeable status; and instruct the FDA and the U.S. Department of Health and Human Services to issue or retract relevant guidance, the summary says.
“Health care needs real reform, and we can start by making prescription drugs more affordable for everyone,” said Rep. Landsman. “This bill will allow innovative drugs to come to market faster and cheaper, and allow pharmacists to swap higher-cost prescriptions for safe and effective alternatives – lowering costs at the pharmacy counter and saving folks real money.”
H.R. 5526 is companion legislation to a bill introduced earlier this year by U.S. Sens. Mike Lee (R-UT) and Maggie Hassan (D-NH) in their chamber.
The measure has gained support from the Biosimilars Forum, the Biosimilars Council, and the Campaign for Sustainable Rx Pricing.