Intas Pharmaceuticals Receives European Commission Approval for Rexatilux, a Lucentis Biosimilar
European Commission Grants Official Marketing Authorization
Intas Pharmaceuticals' Lucentis biosimilar, Rexatilux (ranibizumab), has received final marketing authorization from the European Commission (EC) on June 19, 2026. This approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on April 23, 2026. As a result, Rexatilux is now authorized for sale in the 27 member states of the European Union (EU), as well as in Iceland, Liechtenstein, and Norway, which constitute the European Economic Area (EEA). The biosimilar has demonstrated equivalent efficacy and safety to the originator drug, Lucentis, through rigorous clinical data. This achievement marks a significant step for Intas Pharmaceuticals, a privately held company, in solidifying its position in the global biosimilar market.
Expanding Indications and Market Reach in Ophthalmic Diseases
Rexatilux is a monoclonal antibody fragment that targets vascular endothelial growth factor-A (VEGF-A) to inhibit the formation of abnormal new blood vessels. With this approval, Rexatilux is indicated for the treatment of five major ophthalmic diseases, including neovascular (wet) age-related macular degeneration (nAMD), visual impairment due to diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), macular edema secondary to retinal vein occlusion (RVO), and choroidal neovascularization (CNV). This provides a clinically significant benefit by offering patients in Europe with potentially blinding chronic conditions access to the same treatment benefits as the originator drug. Accord Healthcare, Intas' commercialization subsidiary, is expected to rapidly expand its market share in Europe through its distribution network.
Opportunity for Originator Decline and Biosimilar Price Competition
The originator drug, Lucentis, was a blockbuster drug with global sales of $3.6 billion in 2015. However, due to patent expiration, the entry of biosimilars, and the emergence of next-generation anti-VEGF therapies with longer dosing intervals, global sales have declined to approximately $643 million in 2025. This decline in originator sales creates a significant opportunity for low-cost biosimilar products like Rexatilux. By leveraging price competitiveness, biosimilars can significantly reduce the financial burden on national healthcare systems in Europe and improve patient access to medication.
Intensifying Competition with Next-Generation Drugs
The European anti-VEGF market is characterized by intense competition among various drugs, including the originator Lucentis, aflibercept (brand name Eylea), and the latest bispecific antibody therapy, Vabysmo. Despite the limitation of requiring monthly or bi-monthly intravitreal injections, Rexatilux is expected to leverage the extensive clinical experience and cost-effectiveness of ranibizumab. The ability to switch existing patients who were previously treated with the originator drug and the speed of securing reimbursement in key markets will be crucial for its success in Europe.
The European Commission's (EC) final approval of Rexatilux (ranibizumab) confirms the commercial milestone (Marketed) that will allow Intas to rapidly absorb the Lucentis (Lucentis) originator market, which has shrunk to approximately $643 million annually after patent expiration. In the short term, Accord Healthcare, Intas' sales subsidiary, is expected to actively erode the market share of Roche and Novartis' originator drugs in the price-sensitive European market. In the medium to long term, it is expected to benefit the most from government policies that favor biosimilars by increasing prescription share based on price competitiveness compared to the originator and inducing cost savings in national health budgets. However, short-term price pressure and market saturation due to the entry of aflibercept-based Eylea and the latest generation of complex biosimilar pipelines are identified as obstacles to securing profitability in the future. This approval is expected to be a key contribution for Intas, a private pharmaceutical company, to diversify its antibody therapy portfolio in Europe and solidify its position in the ophthalmic disease area.
Source: EMA (ema)