HHS Secretary Robert F. Kennedy Jr., FDA Commissioner Marty Makary, MD, and CMS Administrator Mehmet Oz, MD, announced new FDA guidance aimed at making biosimilar drug development faster and less costly.
The FDA’s draft guidance eliminates routine requirements for comparative efficacy studies and allows developers to rely more heavily on analytical testing rather than clinical trials, according to information released at an Oct. 29 press conference. It also aims to simplify how biosimilars gain interchangeable status with brand name biologics.
Biologic drugs account for just 5% of prescriptions in the U.S. but represent 51% of total drug spending as of 2024, according to Mr. Kennedy. Although 76 biosimilars have been approved since 2015, their market share remains below 20%. Only 10% of biologics expected to lose patent protection in the next decade currently have biosimilar development.
“By streamlining the biosimilar development process and helping advance interchangeability, we can achieve massive cost reductions for advanced treatments for cancer, autoimmune diseases, and rare disorders affecting millions of Americans,” Dr. Makary said.
The reforms support a broader federal strategy to reduce drug prices, initiated by a May 12 executive order signed by President Donald Trump. The order directed HHS to implement a “most favored nation” pricing model, requiring drugmakers to align U.S. prices with those in other wealthy nations or face trade actions, such as high tariffs on pharmaceuticals. HHS was given 30 days to negotiate price reduction targets, with instructions to propose a rulemaking plan if no progress was made.
Pfizer became the first company to comply with the pricing model, agreeing Sept. 30 to offer nearly all medications to Medicaid at the lowest international price. The company also committed to discounting many consumer medications by 50% to 100% and pledged a $70 billion investment in U.S.-based operations. On Oct. 10, AstraZeneca followed with a similar agreement, including future pricing commitments and a $50 billion domestic investment.
The administration is also preparing to launch TrumpRx.gov in 2026, a federal website that will distribute medications directly to consumers. Cost Plus Drugs, co-founded by Mark Cuban, will partner with the federal TrumpRx.gov platform by feeding daily pricing updates to the site. CVS and Cigna have also partnered with TrumpRx to offer reduced-price fertility drugs beginning in January 2026.
Dr. Oz said additional drugmaker agreements are expected, with a goal of extending most favored nation pricing to 95% of all drugs sold in the U.S. by the end of the administration’s term.
