Celltrion Healthcare’s Vegzelma (biosimilar, bevacizumab) Receives the EC’s Approval for the Treatment of Cancers
Shots:
- The EC has approved Vegzelma, biosimilar bevacizumab referencing EU-approved Avastin for the treatment of metastatic breast cancer, NSCLC, advanced or metastatic RCC, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer
- The approval was based on the totality of the evidence, incl. the P-III trial for metastatic or recurrent non-sq. NSCLC. The results showed that Vegzelma was highly similar to the reference product in terms of efficacy, safety, and PK
- The company has filed for regulatory approval of Vegzelma with the US FDA in Sept 2021 with expected approval in Q3’22. Additionally, the EU patients get a new, safe, and effective treatment option at an affordable price
Ref: Businesswire | Image: Celltrion Healthcare
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