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News

Shanghai Henlius Biotech’s aBLA for Perjeta® Biosimilar HLX11 Accepted by FDA

by Robert S. Schwartz, Ph.D.
February 5, 2025

On February 2, 2025, Shanghai Henlius Biotech announced its aBLA for HLX11, a proposed biosimilar of Genentech’s Perjeta® (pertuzumab), has been accepted by the FDA.  This is the first publicly announced aBLA for a Perjeta® biosimilar.  Perjeta® is FDA-approved for use in patients with various types of HER2-positive breast cancer, in combination with trastuzumab and chemotherapy.

Henlius has an agreement with Organon to commercialize HLX11 in the U.S.  Currently there are no pending patent disputes for Perjeta® biosimilars.

Roche reported U.S. sales of approximately $1.486B USD (1.345B CHF) for Perjeta® in 2024.

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

 

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

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    Laboratory Pharmaceutical Research Biosimilars Biologics TN

    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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