Celltrion’s Omlyclo gets EU nod as first biosimilar to Xolair

24 May 2024
firstwordpharma.com
Drug ApprovalPatent ExpirationPatent Infringement
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.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.