Humanized Anti-IgE monoclonal antibody(Tianchen Biomedical)

Celltrion announced Thursday that the European Commission approved Omlyclo as the first and only biosimilar version of Novartis and Roche’s Xolair (omalizumab). The South Korean company’s product, previously known as CT-P39, is indicated in the EU for the treatment of immune-mediated inflammatory conditions, including allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria While Xolair’s formulation patent expired in Europe in March, Morgan Stanley analysts recently noted that Novartis and Roche are taking legal action against Celltrion over infringement of another patent related to a concentration method for the anti-IgE monoclonal antibody. The patent, EP3805248, is valid until September 2025.However, the analysts said the South Korean drugmaker “doesn't see EP3805248 as an issue, so it thinks it can launch [biosimilar Xolair] in 2H24 as planned.” Celltrion did not disclose a launch date alongside its announcement of Omlyclo’s approval.Meanwhile, the company is also awaiting a decision from the FDA on CT-P39 following a marketing submission filed in March. Xolair, which recently bagged approval as the first medication for food allergy in the US, generated sales of $3.6 billion last year, although its formulation patent is set to expire in the country in November 2025.