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Hyderabad: CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, on Monday said it has reported positive top-line Phase 3 results for BP11, its investigational biosimilar to Xolair, or omalizumab.CuraTeQ said the study met all primary endpoints in patients with chronic spontaneous urticaria receiving the 300 mg dose, demonstrating high comparability with the reference product. The company said it plans to use the results to support regulatory submissions for chronic spontaneous urtic ...Read More >
Hyderabad, April 6 (RAHNUMA): CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has announced positive top-line results from its Phase 3 trial of BP11, an investigational biosimilar to Omalizumab (marketed as Xolair). The study met all primary endpoints, demonstrating strong comparability with the reference drug in treating chronic spontaneous urticaria (CSU) at a 300 mg dose. Conducted across 608 patients at nearly 80 sites in Europe and India, the trial showed precise equivalence in itch s ...Read More >
New Delhi, Aug 12 (PTI) Drug firm Lupin on Tuesday said it has partnered with Switzerland-based Sandoz Group AG to commercialise its biosimilar ranibizumab across multiple regions. Under the terms of the agreement, Sandoz will oversee commercialisation of the product across the European Union (excluding Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, and Malaysia, the Mumbai-based drug maker said in a statement. Lupin will be responsible for manufacturing the product and for regu ...Read More >
New Delhi, Jul 3 (PTI) Biocon Ltd on Thursday said its arm Biocon Biologics Ltd has been granted marketing authorisation by the European Commission for Vevzuo and Evfraxy biosimilars of Denosumab used in the treatment of different bone diseases. The marketing authorisation for the European Union (EU) follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on April 25, 2025, Biocon Ltd said in a regulatory filing. Vevzuo is auth ...Read More >
First & only immuno-oncology drug approved by various regulatory authorities around the world Dr. Reddy's Laboratories has announced the launch of Toripalimab in India. Toripalimab is a New Biological Entity (NBE). It is the only immuno-oncology drug approved by various regulatory authorities around the world such as United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adu ...Read More >
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