Celltrion's third oncology biosim inches closer for marketing in Europe

[Photo by MK DB]

Celltrion’s third oncology biosimilar CT-P16 is just a step short in achieving regulatory clearance for marketing in Europe with a positive opinion from an expert panel of Europe’s health authorities.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a positive opinion for the marketing authorization of the bevacizumab biosimilar referencing Roche’s Avastin, the Korean biosimilar developer said on Monday.

Celltrion plans to launch the product under the brand name of Vegzelma upon the European Commission’s authorization. The EC usually gives a greenlight within one to three months after the CHMP’s recommendation for marketing approval.

The positive opinion was based on the totality of evidence demonstrating the drug’s biosimilarity to Avastin for multiple oncology indications.

If approved, Vegzelma will be the third therapeutic oncology biosimilar in Celltrion’s biosimilar pipeline following blood cancer and breast cancer treatments.

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