FDA, HHS Move to Accelerate Biosimilar Approvals

The Department of Health and Human Services (HHS), along with the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS), has announced a new strategy to accelerate approvals for biosimilars. The initiative hinges on reducing the number of human clinical trials required for certain biosimilars while altering the interchangeability designation process, allowing more biosimilars to be characterized as such.^1,2

Leaders from HHS announced the plan, including HHS Secretary Robert F. Kennedy Jr, CMS Administrator Mehmet Oz, MD, MBA, and FDA Commissioner Marty Makary, MD, MPH. The announcement was first reported by Financial Times and corroborated by Reuters.^1-4

“Biosimilars are often far more affordable to patients and have the promise to significantly lower health care costs in America,” Makary said in an accompanying news release. “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.”²

How Will the FDA Accelerate Biosimilar Approvals?

FDA will release new draft guidance for biosimilar development, saying companies need not conduct large, expansive, comparative human trials in lieu of advanced testing to determine equivalence. The agency released streamlined draft guidance outlining recommendations for comparative efficacy studies (CES) for biosimilars.^1,2

In the guidance, FDA notes that CES’ have generally low sensitivity compared with comparative analytical assessments, and that the removal of requiring resource-intensive human clinical studies can allow for speedier and less-costly development. Makary stated that the new strategy was projected to cut the development time of biosimilars from 5-to-8 years in half while lowering drug prices.¹

FDA is also eliminating “bureaucratic” switching studies for interchangeability status, taking a “strong stand to advance and promote interchangeability,” according to Makary. In their news release, the FDA says that these additional studies can further slow development of biosimilars and sow confusion about their safety. By loosening interchangeability regulations, more pharmacists—and therefore more patients—could gain access to biosimilars.¹

“We don’t have these additional requirements for generics. Moving forward, we won’t for biosimilars,” Makary said.¹

What Are Biosimilars?

Biosimilars are biologic products that are highly like an already approved biologic—called the reference product—with no clinically significant differences in purity, safety, or efficacy. Rigorous comparability processes are employed to ensure that a biosimilar matches the essential features of its reference product.⁵

Within biosimilars are interchangeable biosimilars, a regulatory designation allowing for expanded use of such a product in pharmacies without requiring a physician’s sign-off. Interchangeable biosimilars meet “additional requirements,” such as being able to be used more than once without a higher risk of hazards to safety or decreased effectiveness compared with the reference product.⁵

Both standard and interchangeable biosimilars save patients money because they are cheaper to produce, which drives down its list price. Increased competition between biosimilar versions—since multiple can be produced for one drug—allows for greater price reductions in both the biosimilar and reference products.^5,6

A series of obstacles have prevented greater proliferation of biosimilars across health systems. Patients and providers alike report a lack of education on biosimilars, including their development process and available options for various disease states. Regulatory complexities, including patent litigation and the distinction between interchangeability and biosimilarity, further muddy these waters.⁶

Other Attempts to Lower Drug Costs

The latest announcement builds on recent attempts by HHS and the Trump Administration to lower drug costs in the United States. Earlier in 2025, the FDA announced biosimilar-specific regulatory action, waiving clinical efficacy studies for monoclonal antibody biosimilars. The decision is expected to reduce costs associated with biosimilar development by 90%, accelerate approval timelines by over 70%, and empower more companies to enter the biosimilar market.⁷

More recent efforts have centered around implementing most-favored nation (MFN) pricing to drugs sold in the US, allowing them to be priced at levels comparable to those in other wealthy nations. So far, pharmaceutical giants Pfizer and AstraZeneca have entered into agreements with the White House to lower prices for much of their primary care treatments.^8,9

REFERENCES

1. Biosimilars reform—Accelerating biosimilar development. US Department of Health and Human Services. Livestreamed October 29, 2025. Accessed October 29, 2025. https://www.hhs.gov/live/live-1/index.html#12163

2. FDA moves to accelerate biosimilar development and lower drug costs. News release. US Department of Health and Human Services. Published October 29, 2025. Accessed October 29, 2025. https://www.hhs.gov/press-room/fda-accelerates-biosimilar-development-and-lowers-drug-costs.html

3. Temple-West P. US set to speed up generic biological drugs approval. Financial Times. Published October 29, 2025. Accessed October 29, 2025. https://www.ft.com/content/42fc1c2b-d7eb-408b-b0a7-51650a5cd631

4. US FDA to streamline biosimilar approvals, FT reports. Reuters. Published October 29, 2025. Accessed October 29, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-streamline-biosimilar-approvals-ft-reports-2025-10-29/

5. Iskit AB. Biosimilars and interchangeability: regulatory, scientific, and global perspectives. Euro Journ Pharma Sci. 2025;213(1):107224. doi:10.1016/j.ejps.2025.107224

6. The role of biosimilars in reducing out-of-pocket costs for patients. DrugPatentWatch. Published July 26, 2025. Accessed October 29, 2025. https://www.drugpatentwatch.com/blog/the-role-of-biosimilars-in-reducing-out-of-pocket-costs-for-patients/

7. McGovern G. FDA to waive clinical efficacy studies for monoclonal antibody biosimilars. Pharmacy Times. Published September 2, 2025. Accessed October 29, 2025. https://www.pharmacytimes.com/view/fda-to-waive-clinical-efficacy-studies-for-monoclonal-antibody-biosimilars

8. Halpern L. Pfizer agrees to lower certain drug prices in US, aligning with most-favored nation plan. Pharmacy Times. Published October 1, 2025. Accessed October 29, 2025. https://www.pharmacytimes.com/view/pfizer-agrees-to-lower-certain-drug-prices-in-us-aligning-with-most-favored-nation-plan

9. Halpern L. Breaking news: AstraZeneca, White House announce most-favored-nation deal. Pharmacy Times. Published October 10, 2025. Accessed October 29, 2025. https://www.pharmacytimes.com/view/breaking-news-astrazeneca-white-house-set-to-agree-to-most-favored-nation-deal