Celltrion Healthcare Receives CHMP Positive Opinion of CT-P16 (biosimilar, bevacizumab) as 1L Treatment of Non-Squamous Non-Small Cell Lung Cancer
Shots:
- The EMA’s CHMP has adopted a positive opinion for the marketing authorization of a bevacizumab biosimilar candidate referencing EU-approved Avastin (CT-P16)
- The positive opinion was based on the totality of evidence incl. the P-III study to evaluate the efficacy, PK & safety of CT-P16 vs EU-approved Avastin in patients with metastatic or recurrent nsq. NSCLC. The results were found to be well tolerated and demonstrated biosimilarity b/w the biosimilar and reference bevacizumab
- CT-P16 is an anti-cancer mAb treatment developed as a candidate biosimilar to Avastin (bevacizumab). If CT-P16 is approved, it will be the third therapeutic oncology biosimilar in the company’s biosimilar pipeline
Ref: Celltrion | Image: Celltrion
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