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