News

News

Accord Announces FDA Approval of Neulasta® Biosimilar Ennumo™

by Robert S. Schwartz, Ph.D.
July 13, 2026

On July 9, 2026, Accord announced the May 2026 FDA approval of Ennumo™ (pegfilgrastim-pccg), a biosimilar of Amgen’s Neulasta® (pegfilgrastim).  Ennumo™ is the eighth Neulasta® biosimilar to be approved in the U.S.  According to Samsung Bioepis’s Q2 2026 Biosimilar Market Report, the six marketed Neulasta® biosimilars have gained approximately 87% market share.  Biocon’s Fulphila® (pegfilgrastim-jmdb) is the top selling biosimilar at about 41% of the market.

Currently there are no pending patent disputes related to Neulasta® biosimilars.

Amgen no longer separately reports Neulasta® sales.

For more information on these biosimilars and other biosimilars, please visit BiologicsHQ.com.

 

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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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