Lupin Limited Achieves Milestone in Biosimilar Development with LUBT010

Lupin Limited has announced a major breakthrough in biosimilars with the successful completion of a global Phase 3 clinical trial for LUBT010, its biosimilar to Lucentis. The study confirmed that LUBT010 meets its primary goal of demonstrating equivalent therapeutic efficacy in improving visual acuity for patients with wet age-related macular degeneration (AMD). The results indicated that LUBT010 offers comparable safety and immunogenicity to Lucentis.

Since 2022, Lupin has been marketing a ranibizumab biosimilar under the name RaniEyes in India. Ranibizumab is used to treat various eye conditions, including Neovascular AMD, Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV).

The Phase 3 trial, which followed guidelines from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), involved 600 patients across India, the U.S., the EU, and Russia. Participants received either LUBT010 or Lucentis 0.5 mg through monthly intravitreal injections over 12 months. The data collected will be critical for Lupin’s marketing approval applications with both the FDA and EMA.

Dr. Cyrus Karkaria, President of Lupin Biotech, expressed enthusiasm about the trial results. “The positive outcome of this global Phase 3 study is a significant step forward for our Lucentis biosimilar and underscores our commitment to developing top-quality biosimilars,” he said. “We plan to submit marketing applications for LUBT010 in key global markets within the year.”

Nilesh Gupta, Managing Director of Lupin, highlighted the company’s progress, stating, “This success reflects our ability to create cutting-edge, cost-effective biosimilars. With four products already on the market and several more in development, we are eager to introduce our Ranibizumab biosimilar to the global ophthalmic sector, aiming to improve patient outcomes worldwide.”

Lupin’s continued focus on biosimilars exemplifies its dedication to providing affordable and effective treatments, reinforcing its role as a leader in the pharmaceutical industry.

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