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News

Samsung Bioepis aBLA for Keytruda® (pembrolizumab) Biosimilar SB27 Accepted by FDA

by Robert S. Schwartz, Ph.D.
October 31, 2026

On October 30, 2026, Samsung Bioepis announced the FDA acceptance of an aBLA for SB27, a proposed biosimilar of Merck’s Keytruda® (pembrolizumab).  This application follows Formycon and Zydus’s FYB206 (pembrolizumab), which was accepted earlier in October 2026 (previously reported Formycon and Zydus File First Publicly Disclosed Keytruda® aBLA Along with PGR).  The aBLA for SB27 is based on data from global Phase 1 and 3 comparative efficacy trials and seeks approval for 18 indications.  In contrast, FYB206 was developed without Phase 3 comparative efficacy trials.  Samsung Bioepis has also filed for approval of SB27 in South Korea.

There is currently one pending patent dispute related to a proposed Keytruda® biosimilar, Zydus and Formycon’s PGR2027-00003, challenging Merck’s U.S. Patent No. 12,529,702, which is awaiting an institution decision (previously reported Formycon and Zydus File First Publicly Disclosed Keytruda® aBLA Along with PGR).

Merck reported $31.6 billion in worldwide Keytruda® sales in 2025.

For more information about these and other biosimilars and biosimilar patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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