Multiple Lucentis Biosimilars Advance Through FDA: Two Approvals Secured, One Pending Review
Two new interchangeable Lucentis biosimilars — Lupin's Ranluspec and Formycon/Bioeq's Nufymco — have received FDA approval, while Xbrane's Lucamzi is under review with an October target date. The Lucentis global market was valued at $630 million in 2024.
The U.S. Food and Drug Administration has approved two new interchangeable biosimilars to Lucentis (ranibizumab) in recent months, while a third candidate from a Swedish biotech has been accepted for review, underscoring a wave of competition in the market for therapies treating serious vision-threatening eye conditions.
Lupin announced FDA approval of Ranluspec (ranibizumab-hkdz), its interchangeable biosimilar to Lucentis, covering both vial and pre-filled syringe formats in the same strengths as the reference product — 0.3 mg and 0.5 mg. Ranluspec is a recombinant humanized monoclonal antibody fragment that blocks vascular endothelial growth factor A (VEGF-A). The approval covers several indications, including wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. The company described the approval as Lupin's second U.S. biosimilar authorization, expanding its biologics portfolio.
Separately, Formycon AG and its joint venture Bioeq AG announced that the FDA had approved Nufymco (ranibizumab-leyk) on December 23, 2025, as an interchangeable biosimilar to Lucentis. Zydus Lifesciences Limited has been secured as the commercialization partner for the U.S. market. Nufymco is approved for the same set of retinal indications — wet AMD, diabetic macular edema, diabetic retinopathy, macular edema due to retinal vein occlusion, and myopic choroidal neovascularization — and will be available for all approved indications, offering a more affordable treatment option for patients.
Meanwhile, Xbrane Biopharma has seen its resubmitted Biologics License Application accepted by the FDA for Lucamzi, its Lucentis biosimilar candidate. The agency set a Biosimilars User Fee Act (BsUFA) goal date of October 29, by which the review is expected to be completed. The application was resubmitted after the company addressed issues raised in a Complete Response Letter issued the previous October. The product has already been approved and marketed in Europe under the name Ximluci since 2023.
The growing biosimilar activity comes as the global market for Lucentis was valued at $630 million in 2024 and is projected to reach $1.07 billion by 2031, reflecting a compound annual growth rate of 8% over the forecast period. Genentech holds U.S. rights to Lucentis, while Novartis commercializes the drug in ex-U.S. markets.