Mumbai, India, November 12, 2026
Lupin Limited has announced the European commercial launch of Ranluspec™ (ranibizumab), its biosimilar medicine developed for the treatment of several serious retinal diseases. The launch is being carried out through the company’s commercial partner, Sandoz, and covers European markets excluding Germany. The development follows the European Commission’s approval of Ranluspec in both vial and pre-filled syringe presentations, marking an important milestone in Lupin’s global biotechnology and biosimilar business. Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment designed to inhibit vascular endothelial growth factor A (VEGF-A), a protein involved in abnormal blood vessel formation and leakage in the retina. The medicine is indicated for multiple sight-threatening conditions, including wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy and choroidal neovascularization. Through the European launch, Lupin and Sandoz aim to expand the availability of high-quality biosimilar treatments for patients requiring specialized ophthalmic care. The announcement also strengthens Lupin’s international biosimilar portfolio and demonstrates its continued focus on developing and commercializing complex biologic medicines in regulated pharmaceutical markets.
Ranluspec Targets Multiple Sight-Threatening Retinal Diseases
Ranluspec is a biosimilar version of ranibizumab, a targeted biological medicine used in the management of several retinal vascular disorders. Its mechanism of action involves binding to and inhibiting VEGF-A, a signaling protein that promotes the growth of abnormal blood vessels and increases vascular permeability. Excessive VEGF-A activity can contribute to abnormal blood vessel formation and fluid leakage within the retina, potentially leading to progressive visual impairment. By blocking VEGF-A activity, ranibizumab helps reduce abnormal vascular growth and leakage, supporting the management of conditions that threaten central vision. The approved indications for Ranluspec include neovascular (wet) age-related macular degeneration (AMD), a condition characterized by abnormal blood vessel growth beneath the retina. It is also indicated for macular edema following retinal vein occlusion, where blocked retinal blood vessels can cause fluid accumulation and swelling. Additional indications include diabetic macular edema, proliferative diabetic retinopathy and choroidal neovascularization. The availability of both vial and pre-filled syringe presentations provides healthcare professionals with different administration formats for appropriate clinical settings. The European commercialization represents an important development for patients and healthcare providers seeking additional biosimilar options in ophthalmology.
Sandoz Partnership Supports European Commercial Expansion
The European launch highlights the strategic collaboration between Lupin and Sandoz, combining Lupin’s biotechnology development and manufacturing capabilities with Sandoz’s commercial infrastructure and established presence across international pharmaceutical markets. Under the collaboration, Lupin is responsible for manufacturing and regulatory activities, while Sandoz manages commercialization across the agreed European territories. The partnership was established to support the introduction of Lupin’s ranibizumab biosimilar into multiple international markets. The European Commission previously granted marketing authorization for Ranluspec following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The regulatory approval covered both vial and pre-filled syringe presentations and established the foundation for the current commercial rollout. Thierry Volle, President of EMEA and Emerging Markets at Lupin, stated that the European launch advances the company’s strategy of bringing high-quality biosimilars to more patients affected by retinal and choroidal vascular diseases. He emphasized the importance of working with Sandoz to expand access to this treatment across the region. Dr. Cyrus Karkaria, President of Lupin’s Biotech Business, highlighted that the launch demonstrates the company’s growing capabilities in biosimilars by combining scientific expertise with biologics manufacturing strengths.
Advertisement
Lupin Strengthens Its Global Biosimilar Portfolio
The introduction of Ranluspec across European markets represents another milestone in Lupin’s biotechnology and biosimilar expansion strategy. The company continues to invest in the development, manufacturing and commercialization of biological medicines designed to address significant unmet medical needs. Biosimilars are biological medicines developed to demonstrate high similarity to an already approved reference biologic, with no clinically meaningful differences in safety, purity and potency. Their development involves extensive analytical characterization, manufacturing controls and regulatory evaluation to establish biosimilarity. For ophthalmology, the availability of additional ranibizumab biosimilar options may support greater competition and potentially improve treatment accessibility across healthcare systems. However, actual affordability and patient access will depend on local pricing, reimbursement policies and healthcare procurement arrangements. The European launch of Ranluspec reinforces Lupin’s position in the global biosimilar market and highlights the importance of strategic partnerships in bringing complex biological medicines to international markets. Continued commercialization and adoption across European healthcare systems will determine the product’s broader impact on retinal disease management.
Source: Lupin Limited press release
