Lupin Completes Phase 3 Trials for Lucentis® Biosimilar

On August 5, 2024, Lupin Limited, a major player in the global pharmaceutical industry, announced the successful completion of a Phase 3 clinical trial for LUBT010. This biosimilar candidate to Lucentis has shown promising results, meeting the primary endpoint of therapeutic equivalence in improving visual acuity for patients with wet Age-related Macular Degeneration (AMD). The trial also demonstrated comparable safety and immunogenicity profiles between LUBT010 and Lucentis.

Lupin has been actively marketing its ranibizumab biosimilar in India since 2022 under the brand name RaniEyes. Ranibizumab, a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment, is utilized in treating 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 clinical trial was meticulously designed as a global study, adhering to the guidelines set forth by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The trial included 600 patients from diverse regions such as India, the USA, Europe, and Russia. Participants were randomized to receive either LUBT010 or Lucentis 0.5 mg through intravitreal injections administered monthly over a one-year period. Throughout this duration, patients were closely monitored for efficacy, safety, and immunogenicity. The data gathered from this study will be integral to Lupin's upcoming marketing approval applications to both the U.S. FDA and the EMA.

Dr. Cyrus Karkaria, President of Lupin Biotech, expressed his satisfaction with the trial results, highlighting the achievement as a significant milestone in the development of their Lucentis biosimilar. "This accomplishment reaffirms our dedication to developing high-quality biosimilars to address patient needs," he stated. Lupin plans to file marketing applications for LUBT010 in all major global markets within the year.

Nilesh Gupta, Lupin's Managing Director, also commented on this milestone, attributing it to the capabilities of their Biosimilars team in developing innovative and cost-effective products. Gupta noted that Lupin has already commercialized four products and has several others in various stages of clinical development. He emphasized the company's commitment to introducing their high-quality Ranibizumab Biosimilar to the global ophthalmic market, aiming to significantly impact patients' lives worldwide.

Lupin Limited, headquartered in Mumbai, India, is a transnational pharmaceutical company driven by innovation. The company specializes in developing and commercializing a wide array of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) across more than 100 markets, including the USA, India, South Africa, the Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

Lupin holds a leadership position in cardiovascular, anti-diabetic, and respiratory segments and maintains a substantial presence in the anti-infective, gastrointestinal, central nervous system, and women's health areas. It is notably the third-largest pharmaceutical company in the USA by prescription volume. In the fiscal year 2024, Lupin invested 7.8% of its revenue into research and development.

The company operates 15 manufacturing sites and 7 research centers globally, employing over 20,000 professionals. Lupin has consistently been recognized as an excellent workplace within the Biotechnology and Pharmaceuticals sector.