Lupin, through its commercial partner Sandoz, has launched Ranluspec, a biosimilar of ranibizumab, across Europe, excluding Germany.
The launch follows the European Commission’s approval of Ranluspec in February 2026 in both vial and pre-filled syringe presentations, marking a step towards expanding access to biologic treatment options for patients with retinal diseases.
Ranibizumab is a recombinant humanised IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A (VEGF-A). Ranluspec is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular oedema following retinal vein occlusion, diabetic macular oedema, proliferative diabetic retinopathy and choroidal neovascularisation.
Ranluspec has demonstrated equivalent efficacy and comparable safety to its reference medicine, Lucentis, developed by Genentech, which markets the drug in the United States. Internationally, Lucentis is marketed by Novartis.
“The launch of Ranluspec in Europe advances Lupin’s strategy of bringing high-quality biosimilars to more patients suffering from retinal and choroidal vascular diseases. Together with Sandoz, we will expand access to this important treatment across the region,” said Thierry Volle, President, EMEA and Emerging Markets, Lupin.
Dr Cyrus Karkaria, President – Biotech Business, Lupin, added, “The launch of Ranluspec reinforces our growing capabilities in biosimilars as it brings together our scientific expertise and manufacturing capabilities in biologics. It underscores our commitment to addressing unmet needs while supporting more sustainable healthcare systems.”
Christophe Delenta, President Europe, Sandoz, said, “The launch of Ranluspec gives more patients access to a high-quality and affordable version of the medicine they need, while supporting the long-term sustainability of European healthcare systems.”
Christophe Delenta, President Europe at Sandoz, said timely access to effective and affordable treatment was essential for patients with retinal diseases to preserve their vision, independence and quality of life.
“The launch of Ranluspec gives more patients access to a high-quality and affordable version of the medicine they need, while supporting the long-term sustainability of European healthcare systems,” he added.
Sandoz and Lupin announced a commercial partnership in August 2025 for the commercialisation and supply of a ranibizumab biosimilar. Under the agreement, Sandoz holds exclusive commercialisation rights for Ranluspec across the European Union, excluding Germany, and semi-exclusive rights in France. In Germany, Sandoz is commercialising Epruvy (ranibizumab) under a separate agreement.
Other key announcements from Lupin
The Ranluspec launch follows several key announcements by Lupin this month, spanning product launches, regulatory approvals, financial performance and leadership appointments.
Lupin launches Raltegravir Tablets in the US
Earlier this month, Lupin announced the launch of Raltegravir Tablets USP, 600 mg, in the US, following approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).
The tablets are bioequivalent to Merck Sharp & Dohme’s reference listed drug (RLD), Isentress HD Tablets, 600 mg. They are indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 40 kg.
Lupin is the exclusive first-to-file applicant for the product and is eligible for 180-day generic drug exclusivity.
US FDA approves Amifampridine Tablets
The company also received US FDA approval for its ANDA for Amifampridine Tablets, 10 mg.
The tablets are bioequivalent to Catalyst Pharmaceuticals’ reference listed drug, Firdapse Tablets, 10 mg, and are indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disease that causes severe muscle weakness.
Lupin is among the first ANDA applicants and is eligible for 180 days of shared generic drug exclusivity
Lupin reports Q2 FY27 financial results
Lupin reported its financial performance for the quarter ended September 30, 2026, with gross profit increasing 15.4% to INR 57,774 million, compared with INR 50,066 million in the corresponding quarter of the previous fiscal year. The company reported a gross margin of 74.2%.
Commenting on the performance, Nilesh Gupta, managing director, Lupin, said, “We delivered a strong first half of FY27, underpinned by solid growth across key markets and sustained profitability. While we remain mindful of near-term challenges, we are confident in our long-term growth prospects, supported by the strength of our portfolio, continued investments in R&D and commercial capabilities, and our unwavering focus on disciplined execution.”
Lupin appoints Akhil Gupta as Independent Director
Lupin also appointed Akhil Gupta as an Independent Director to its Board.
Gupta currently serves as Non-Executive Independent Chairman of 360 ONE WAM, Coforge and Valuedrive Technologies (Spinny). He is also an Independent Director at Lodha Developers and Zepto, and a Nominee Director at Acevector Ltd.
In addition, he is President of the Telecom Sector Skill Council, a member of the Confederation of Indian Industry (CII) National Committee on Telecom & Broadband and the CII Task Force on Insolvency and Bankruptcy, and Chairman of Inversion Advisory Services.
