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Shanghai Henlius Biotech Announces FDA Acceptance of aBLA for Proposed Avastin® Biosimilar HLX04

by Robert S. Schwartz, Ph.D.
January 16, 2026

On January 13, 2026, Shanghai Henlius Biotech announced the FDA acceptance of an aBLA for HLX04, its proposed biosimilar of Genentech’s Avastin® (bevacizumab).  Other pending publicly announced aBLAs for Avastin® biosimilars include Samsung Bioepis’s SB8 and Centus / Fujifilm Kyowa Kirin’s FKB238, both accepted by the FDA in November 2019.  Six Avastin® biosimilars have been approved in the U.S. to date, beginning with Amgen / Allergan’s Mvasi® (bevacizumab-awwb), FDA-approved in September 2017.  According to Samsung Bioepis’s Q4 2025 Biosimilar Market Report, Avastin® biosimilars account for about 92% of the bevacizumab market share, with Mvasi® capturing the largest share of the market at about 54%.

Shanghai Henlius Biotech has a number of approved biosimilars in the U.S., including Herceptin® (trastuzumab) biosimilar Hercessi™ (trastuzumab-strf) (previously reported Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf)), Prolia® / Xgeva® (denosumab) biosimilars Bildyos® / Bilprevda® (denosumab-nxxp) (previously reported FDA Approves Prolia® / Xgeva® (denosumab) Biosimilars: Henlius’s Bildyos® / Bilprevda®, Biocon’s Bosaya™ / Aukelso™, and Gedeon Richter’s Enoby™ / Xtrenbo™), and Perjeta® (pertuzumab) interchangeable biosimilar Poherdy® (pertuzumab-dpzb) (previously reported FDA Approves First Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy®).

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

For more information on these and other biosimilars and related patent disputes, 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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