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# One-Third of Biosimilars Approved Not Launched: Report
- URL: https://www.fdaweb.com/one-third-of-biosimilars-approved-not-launched-report/
- Published: 2025-04-25T12:00:00.000Z
- Updated: 2026-09-14T15:10:18.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159070

FDA has approved a total of 73 biosimilars across 19 unique biological molecules, but so far only 48 (66%) of these have been launched in the U.S. market, according to a new Samsung Bioepis’ biosimilar market [report.](https://www.samsungbioepis.com/en/etc/gadown.do?filename=SB+Biosimilar+Market+Report+Q2+2025.pdf&utm%5Fsource=pdfClick&utm%5Fmedium=filedown&utm%5Fcampaign=marketReport) On average, biosimilars have gained 52% market share within five years post initial launch, it says, adding that each molecule has demonstrated a unique biosimilar “fast or slow uptake.” For example, fast uptake speed was seen in oncology, ophthalmology, and pegfilgrastim biosimilars, the report found, adding that five years post-launch, average biosimilar market share reached 81%. And a slow uptake speed was seen in immunology, filgrastim, epoetin alfa, and insulin glargine biosimilars (on average, only a 25% biosimilar market share was achieved by Year 5).

The report also touched on opportunities for streamlining biosimilar development, such as a growing consensus that clinical comparative effectiveness studies (CES) often do not provide additional meaningful information for regulatory decision-making. Regulators and industry experts have recognized the limitations of CES as they are not likely to be additionally informative with respect to the small differences typically observed in analytical comparisons, particularly if comparative pharmacokinetic studies show similar profiles, the report notes.

FDA is increasingly moving towards a more flexible, risk-based approach, and has acknowledged that CES may not always be necessary and can be waived in certain circumstances, particularly if robust analytical comparability data demonstrates high similarity between the biosimilar and the reference product. The report notes that the European Medicines Agency recently released a reflection paper aimed at identifying opportunities to waive CES requirements for biosimilars. For biosimilars where high similarity to the reference product is established through analytical and functional data, and where the mechanism of action is well-understood, CES “may be deemed unnecessary,” it says.