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aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA Resubmission

by Robert S. Schwartz, Ph.D.
January 7, 2025

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  The aBLA was previously withdrawn from FDA consideration in May 2022, resubmitted in April 2023, and received a Complete Response Letter in April 2024 (previously reported Biosimilar Launch and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.

For more information on biosimilar aBLA filings, 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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