Celltrion Files First U.S. BLA for Omalizumab Biosimilar CT-P39
Celltrion has made a significant move in the biopharmaceutical market by submitting a Biologics License Application (BLA) for its biosimilar, CT-P39, to the U.S. Food and Drug Administration (FDA). The application seeks approval for all indications currently approved for XOLAIR, which had global sales of $3.89 billion in 2022. This marks the first time a company has sought marketing approval for an omalizumab biosimilar in the United States.
CT-P39, developed by Celltrion USA, is a biosimilar to XOLAIR (omalizumab), a medication used to treat various conditions including asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria. Coherus BioSciences was the first to initiate a market application procedure for an omalizumab biosimilar in the U.S., but Celltrion is the first to submit a BLA. Notably, CT-P39 demonstrated comparable efficacy and safety to XOLAIR in Phase 3 studies, particularly for chronic spontaneous urticaria.
The potential approval of CT-P39 could significantly impact the stock market, as XOLAIR's global sales in 2022 reached $3.89 billion, according to IQVIA. Biosimilars, like CT-P39, are expected to increase patient access to treatments and potentially reduce healthcare costs.
Celltrion's BLA submission for CT-P39, an omalizumab biosimilar, opens the door to increased competition in the U.S. market for XOLAIR. If approved, CT-P39 could offer a more affordable treatment option for patients with asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and chronic spontaneous urticaria. The FDA's review process will determine the timeline for CT-P39's potential market entry.
Read also:
- Overweight women undergoing IVF have a 47% higher chance of conceiving naturally post-weight loss
- Bonsai Trees from Evergreen Species: Exploring Growth Characteristics & Distinct Qualities
- What temperatures may make walking your canine companion uncomfortable?
- Title: Information About Beovu: Potency, Form, Usage, and Additional Details
