Posted by Michael Wonder on 27 Jun 2022
Celltrion Healthcare receives CHMP positive opinion for biosimilar bevacizumab, Vegzelma (CT-P16)
27 June 2022 - The positive opinion is based on the totality of evidence including the Phase III study to evaluate efficacy, pharmacokinetics, and safety between CT-P16 and EU approved Avastin in people with metastatic or recurrent non-squamous non-small-cell lung cancer as first-line treatment.
Celltrion Healthcare announced today that the CHMP of the EMA has adopted a positive opinion for the marketing authorisation of a bevacizumab biosimilar candidate, referencing EU-approved Avastin, Vegzelma (CT-P16).
