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News

FDA Approves Accord’s Neupogen® Biosimilar Filkri™ (filgrastim-laha)

by Robert S. Schwartz, Ph.D.
February 19, 2026

On February 17, 2026, Accord BioPharma announced the FDA approval of Filkri™ (filgrastim-laha), a biosimilar of Amgen’s Neupogen® (filgrastim).  Filkri™ is the fifth Neupogen® biosimilar to be approved by the FDA and will be entering an established biosimilar market.  In March 2015, Zarxio® (filgrastim-sndz) was the first biosimilar to be approved in the U.S. According to Samsung Bioepis’s 1Q 26 Biosimilar Market Report, Zarxio® has obtained approximately 40% of the filgrastim market share in its over 10 years on the market.  Biosimilars account for approximately 77% of the total filgrastim market share.

Currently, there are no ongoing patent disputes related to Neupogen® biosimilars.

For more information on 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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