The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)
Shots:
- Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)
- The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK profile of Omlyclo vs Xolair among CSU patients for up to wk.40. Results demonstrated comparable efficacy, safety & immunogenicity
- Moreover, Omlyclo is currently under the US FDA’s review after its regulatory submission in Mar 2024
Ref: Celltrion | Image: Celltrion
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
