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Newswires & Feeds Content Syndication Digital Signage Services Radio News Services Intelligent Investor Biotech Investor Latest News Videos Free Content Press Releases Biotech Daily Dose Lupin Wins FDA Approval For Ranluspec Biosimilar To Lucentis By TajSabreen Ahamed ✉ | Published: 6/4/2026 10:56 PM ET Addas your preferred news source on Google Lupin Ltd., (NSE: LUPIN) announced that the U.S. FDA has approved Ranluspec (ranibizumab-hkdz), its interchangeable biosimilar to Lucentis (Genentech). The approval covers both vial and pre-filled syringe formats in the same strengths as Lucentis,
0.3 mg and 0.5 mg. Ranluspec is a recombinant humanized monoclonal antibody fragment that blocks vascular endothelial growth factor A. It is indicated for several vision-threatening conditions, including wet-age related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization. Company executives highlighted the milestone as Lupin’s second U.S. biosimilar approval, underscoring its growing biologics portfolio. CEO Vinita Gupta said the launch expands patients’ access to proven vision therapies, while Managing Director Nilesh Gupta emphasized the company’s manufacturing
capabilities and commitment to affordable treatments. Dr. Cyrus Karkaria, President of Biotechnology at Lupin, added that the FDA nod reinforces Lupin’s expertise in biologics development and its mission to broaden access to advanced therapies worldwide. Headquartered in Mumbai, Lupin operates across more than 100 markets, with strengths in branded and generic formulations, complex generics, biotechnology, and APIs. The company runs 15 manufacturing sites and seven research centers globally, supported by over 24,000 employees. Lucentis’ global market was valued at $630 million in 2024 and is
projected to reach $1.07 billion by 2031, reflecting a CAGR of 8% over the forecast period, with Genentech holding U.S. rights and Novartis commercializing ex-U.S. markets. LUPIN has traded between INR 1,836.80 and INR 2,494 over the past year. The stock closed Thursday’s trading at INR 2,249, down 0.50%. For comments and feedback contact: editorial@rttnews.com Business News Slide Shows Biotech Stocks Facing FDA Decision In June 2026 Biotech Stocks Facing FDA Decision In May 2026 Biotech Stocks Facing FDA Decision In April 2026 Latest Updates
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Lupin, Ranluspec, ranibizumab-hkdz, Lucentis biosimilar, FDA approval, interchangeable biosimilar, wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion macular edema