Positive CHMP opinion for biosimilar for cancer treatment

pharmafile | June 28, 2022 | News story | Manufacturing and Production  

The CHMP of the EMA has adopted a positive opinion for the marketing authorisation of a bevacizumab biosimilar candidate, Vegzelma. The oncology biosimilar candidate from Celltrion Healthcare is the third from the company to be recommended for marketing authorisation by the EMA.

The positive opinion from the CHMP was supported with a comprehensive data package, and evidence demonstrating biosimilarity to the reference product for indications including metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer.

“If approved, Vegzelma (CT-P16) will be the third therapeutic oncology biosimilar in our biosimilar pipeline,” said Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion, in a statement. “Today’s positive CHMP opinion underscores Celltrion’s strong heritage in oncology and ongoing commitment to bringing high quality and innovative biosimilars to the market, providing additional treatment options for people living with cancers.”

CT-P16 is an anti-cancer monoclonal antibody treatment, developed as a candidate biosimilar to Avastin® (bevacizumab). CT-P16 (bevacizumab biosimilar) is a recombinant humanised monoclonal antibody, which binds to VEGF, the key driver of vasculogenesis and angiogenesis.

Vasculogenesis is the differentiation of precursor cells into endothelial cells, and the formation of a primitive vascular network. Angiogenesis is the growth of new capillaries from pre-existing blood vessels.

In binding to VEGF, CT-P16 thereby neutralises the biological activity of VEGF, which regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature. This works to inhibit tumour growth in patients.

A global Phase III clinical trial is being conducted to compare efficacy and safety of CT-P16 and EU-approved Avastin as first-line treatment for metastatic or recurrent non-squamous non-small cell lung cancer.

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