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FDA Approves Xbrane and STADA’s Lucentis® Biosimilar Lucamzi™ (ranibizumab-blrz)

by Robert S. Schwartz, Ph.D.
October 30, 2026

On October 29, 2026, the FDA approved Xbrane and STADA’s Lucamzi™ (ranibizumab-blrz) as a biosimilar of Genentech’s Lucentis® (ranibizumab).  Lucamzi™’s approval comes after resolving issues in two Complete Response Letters issued in 2024 and 2025 (previously reported aBLA Resubmissions: Xbrane’s Xlucane (ranibizumab) and Alvotech’s AVT05 (golimumab) and AVT06 (aflibercept); Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf); aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA Resubmission).

Lucamzi™ is the fifth Lucentis® biosimilar approved in the U.S., and the companies are preparing for a launch in 2027.

There are no pending patent disputes related to Lucentis® biosimilars.

Roche reported U.S. sales of 58 million CHF (approximately $73 million USD) for Lucentis® in 2025.

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.

    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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