FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs
On October 29, 2025, the FDA released its draft guidance updating the framework for biosimilar reviews, aiming to streamline development and reduce costs41011.
The new draft guidance proposes that many biosimilars may be approved without the previously required comparative efficacy study (CES), allowing developers to instead rely on comparative analytical assessments (CAA) and pharmacokinetic data491417.
This regulatory shift acknowledges advances in analytical technologies and is expected to cut years and millions from biosimilar development timelines4155.
The FDA emphasizes a case-by-case evaluation; no strict rules are being imposed for when CES can be waived41217.
Early consultation with the FDA is encouraged for biosimilar developers to clarify evidentiary expectations and understand potential legal challenges412.
Alongside the review changes, FDA finalized its long-debated biosimilar naming guidance:
biosimilars will share the same international nonproprietary name (INN) as their reference biologic, but with an added four-letter, meaningless suffix to improve drug tracking and safety26.
The revised guidance reflects broader efforts to promote interchangeability and increase competition in the biologics marketplace, ultimately aiming to reduce drug costs for patients and payers311.
Sources:
2. https://www.biosimilardevelopment.com/doc/fda-releases-long-awaited-guidance-on-biologics-biosimilars-naming-0001
3. https://citizenportal.ai/articles/6730072/HHS-FDA-announce-draft-guidance-to-speed-biosimilars-push-interchangeability-to-lower-drug-costs
4. https://natlawreview.com/article/new-fda-guidance-could-speed-biosimilar-approvals-and-cut-costs
5. https://www.skadden.com/insights/publications/2025/11/fda-policy-changes-could-bring-some-biosimilars
6. https://www.biopharmadive.com/news/fda-biosimilar-naming-guidance/433965/
9. https://www.ajmc.com/view/fda-guidance-to-remove-one-of-the-largest-barriers-to-biosimilar-development
10. https://www.bhfs.com/insight/fda-issues-updated-framework-for-biosimilar-reviews/
11. https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs
12. https://www.axinn.com/en/insights/axinn-viewpoints/streamlining-the-studies-new-fda-draft-guidance-aims-to-speed-up-biosimilar-deve
14. https://www.jdsupra.com/legalnews/fda-rethinks-need-for-comparative-8509505/
15. https://www.polsinelli.com/publications/fda-guidance-speeds-biosimilar-approvals-cut-costs
17. https://www.alston.com/en/insights/publications/2025/11/fda-comparative-efficacy-studies-biosimilars