On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Celltrion previously reached a settlement agreement allowing Steqeyma™ to enter the U.S. market by March 7, 2025. Based on public announcements, there is only one pending aBLA for a Stelara® biosimilar, Bio-Thera’s BAT2206, accepted by the FDA in July 2024.
Under a settlement agreement with Amgen, Wezlana™ (ustekinumab-auub), the first FDA-approved Stelara® biosimilar was able to launch as of January 1, 2025 (previously reported First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.), however no launch has been announced to date. There are no currently pending patent disputes related to Stelara® biosimilars.
Johnson & Johnson reported Stelara® U.S. sales of $6.97B in 2023.
On December 31, 2024, Xbrane announced the resubmission of its aBLA for Xlucane™ (ranibizumab), a proposed biosimilar of Genentech’s Lucentis® (ranibizumab). The aBLA was previously withdrawn from FDA consideration in May 2022, resubmitted in April 2023, and received a Complete Response Letter in April 2024 (previously reported Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf)). Based on public announcements, Xbrane has the only pending aBLA for a Lucentis® biosimilar.
Two previously approved biosimilars of Lucentis®, Samsung Bioepis / Biogen’s Byooviz™ (ranibizumab-nuna), and Sandoz’s Cimerli™ (ranibizumab-eqrn) (acquired from Coherus) launched in June and October 2022 respectively. They have since gained approximately 56% of the ranibizumab market share according to a Q4 2024 Biosimilar Market Dynamics report from Samsung Bioepis.
Novartis and Roche reported 2023 Lucentis® sales of approximately $1.475 billion USD.
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The author would like to thank April Breyer Menon for her contributions to this article.
