Omalizumab biosimilar posts positive Phase 3

Aurobindo’s biologics arm, CuraTeQ, says its omalizumab biosimilar BP11 cleared a large Phase 3 trial, hitting all primary endpoints in 608 patients with chronic spontaneous urticaria. The company said the study ran at roughly 80 sites across seven European countries and India, and used change from baseline in ISS7 itch score at week 12 as the main endpoint for both FDA and EMA submissions. It now plans to file in Europe and the United States by the end of the second quarter of 2026 (aurobindo.com, expresspharma.in). That matters because BP11 is not chasing a small niche product. It is chasing Xolair, the anti-IgE antibody sold as omalizumab, a long-running biologic used in allergic asthma and chronic hives, with newer use in nasal polyps and food allergy in the United States. Novartis reported $1.723 billion in 2025 Xolair sales from continuing operations, which is large enough to make any credible biosimilar entrant worth watching (novartis.com, accessdata.fda.gov, ema.europa.eu). The disease CuraTeQ chose for its pivotal test also makes sense. Chronic spontaneous urticaria is not just “hives.” It is a condition that can drag on for months or years, with relentless itching, swelling, and sleep disruption. Xolair has become a standard add-on when antihistamines fail, and in Europe the approved CSU dose is 300 mg every four weeks, which is the same dose CuraTeQ highlighted in its readout. A biosimilar does not need to prove it is better. It needs to show there is no meaningful clinical difference from the reference drug, and that is exactly the lane BP11 is trying to stay in (ema.europa.eu, xolairhcp.com, curateqbio.com). Still, “positive top-line results” is not the same thing as full evidence. CuraTeQ has disclosed the broad outline of the trial and said efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamics were comparable to Xolair, but it has not yet published a full dataset in a paper or conference presentation. That leaves the most important remaining questions exactly where they usually sit in biosimilars until regulators review the package: how tight the equivalence margins were, how clean the safety split looked, and whether any immunogenicity signal showed up in subgroups (aurobindo.com, thehindubusinessline.com). Those safety details matter more with omalizumab than with many routine injectables because the originator carries a boxed warning for anaphylaxis in the United States. The FDA label says reactions can occur after the first dose or even after more than a year of treatment, which is why omalizumab started life as a clinic-administered drug with observation afterward. Xolair has since expanded into self-administration for some patients, but that only raises the bar for confidence in post-launch pharmacovigilance if a biosimilar reaches market (accessdata.fda.gov, novartis.com). CuraTeQ is building this candidate inside a broader biosimilars push from Aurobindo, which has been trying to move beyond classic small-molecule generics into complex biologics. BP11 gives that strategy a clearer shape. If the EMA and FDA accept the filings on the timeline the company laid out, regulators will soon be looking at whether a 608-patient urticaria trial, plus the analytical comparability package behind it, is enough to open the door to a cheaper version of one of immunology’s older blockbusters by the end of Q2 2026 (aurobindo.com, economictimes.indiatimes.com).