Aurobindo Pharma's biologics subsidiary CuraTeQ Biologics announced Wednesday it has formally submitted a marketing authorisation application to the European Medicines Agency for BP11, its omalizumab biosimilar referencing Novartis's Xolair, following the successful completion of its pivotal Phase 3 clinical trial. The submission marks a major milestone for the Hyderabad-based company as it accelerates its global biosimilar expansion strategy.

The Phase 3 trial, which enrolled 608 patients across European sites, met all primary clinical endpoints, demonstrating equivalent efficacy and a comparable safety profile to the reference biologic. Omalizumab is a monoclonal antibody widely used for the treatment of moderate-to-severe allergic asthma and chronic idiopathic urticaria, a market estimated at over $3 billion annually across global markets.

CuraTeQ's Chief Executive confirmed the EMA filing was the first of several planned submissions, with applications to the Central Drugs Standard Control Organisation in India and the United Kingdom's Medicines and Healthcare products Regulatory Agency expected to follow in the second quarter of 2026. The company said it is also evaluating a pathway for the United States market through the FDA's 351(k) biosimilar approval route.

Industry analysts noted the timing positions CuraTeQ ahead of several competing omalizumab biosimilar developers in the European regulatory queue, potentially allowing a commercial launch in Europe as early as mid-2027 if the EMA review proceeds on standard timelines. The biosimilar market for omalizumab is set to intensify as Xolair's core patents have largely expired in major jurisdictions.

Aurobindo Pharma shares responded positively on the Bombay Stock Exchange, gaining approximately 2.1 percent in early Wednesday trading, reflecting investor optimism about the company's biologics pipeline. CuraTeQ has several additional biosimilar candidates in mid-to-late stage development targeting immunology and oncology indications, according to the company's 2026 pipeline disclosures.