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FDA Approves Lupin’s Ranluspec™ (ranibizumab-hkdz) as Fourth Interchangeable Biosimilar of Lucentis®

by Robert S. Schwartz, Ph.D.
June 4, 2026

On June 2, 2026, the FDA approved Lupin’s Ranluspec™ (ranibizumab-hkdz) as the fourth interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab).  According to Lupin’s press release, this is the first interchangeable ranibizumab biosimilar to be approved in 0.3mg and 0.5mg vial and prefilled syringe presentations. Ranluspec™ is approved for patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV).

The approval follows that of Byooviz® (ranibizumab-nuna) in September 2021, Cimerli® (ranibizumab-eqrn) in August 2022, and Nufymco™ (ranibizumb-leyk) in December 2025 (previously reported FDA Approves Third Lucentis® (ranibizumab) Interchangeable Biosimilar: Formycon’s Nufymco™). Xbrane’s aBLA for Xlucane (ranibizumab) is currently pending at the FDA after being resubmitted in June 2026.

Byooviz® was the first Lucentis® biosimilar to launch in July 2022, followed by Cimerli® in October 2022.  After reaching an approximately 50% market share, Cimerli®‘s commercialization was temporarily paused in early 2025.  Currently, according to Samsung Bioepis’s 2Q 2026 Biosimilar Market Report, Lucentis® maintains approximately 98% market share.

There are no pending patent proceedings relating to Lucentis® biosimilars.

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

For more information on biosimilar approvals and patent proceedings, 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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