CHMP positive opinions for biosimilars Vegzelma and Ranivsio

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of its bevacizumab biosimilar referencing Avastin, Vegzelma (CT-P16), from South Korea-headquartered Celltrion Healthcare.

The positive opinion marks Celltrion’s third oncology biosimilar to be recommended for marketing authorization by the EMA and was based on the totality of evidence demonstrating biosimilarity to Roche’s (ROG: SIX) Avastin for multiple oncology indications.

The therapeutic equivalence of CT-P16 and reference bevacizumab was demonstrated by way of objective response rate (ORR) during the induction study period. In addition, CT-P16 was well tolerated and showed a comparable safety profile to reference bevacizumab.