CHMP Gives Thumbs Up for Celltrion, Formycon Biosimilars

The European Committee for Medicinal Products for Human Use (CHMP) gave positive opinions, essentially recommending for the European Commission to grant marketing authorization, for 2 biosimilar candidates: Celltrion Healthcare’s bevacizumab candidate (Vegzelma; CT-P16) and Formycon’s prospective ranibizumab product (FYB201).

Vegzelma references Avastin and, if approved, would be used in the treatment of several types of cancer, 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.

The positive opinion for the bevacizumab candidate is based on evidence from a phase 3 study that established comparable safety, efficacy, pharmacokinetic profiles between CT-P16 and the EU-approved version of Avastin in patients with metastatic or recurrent nonsquamous non–small cell lung cancer. In the study, CT-P16 was found to be well tolerated by patients and demonstrated biosimilarity between the biosimilar and reference product.

“If approved, Vegzelma (CT-P16) will be the third therapeutic oncology biosimilar in our biosimilar pipeline….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,” said Kevin Byoung Seo Choi, senior vice president and head of the marketing division at Celltrion Healthcare, in a statement.

FYB201 is a biosimilar to Lucentis, which is used to treat patients with ophthalmic conditions, such as neovascular (or wet) age-related macular degeneration, macular edema, and diabetic retinopathy.

The CHMP recommended the biosimilar based on data from a randomized, double-blind, multicenter, parallel-group phase 3 study that established biosimilarity between FYB201 and Lucentis in patients with wet age-related macular degeneration.

Formycon has licensing agreements with Teva Pharmaceuticals and Bioeq, who will have the distribution rights for FYB201 in Europe and other territories upon approval.

If Vegzelma is granted marketing authorization, it will become 1 of 8 bevacizumab biosimilars approved for use in the European Union. Byooviz is currently the only ranibizumab biosimilar approved by the European Medicines Agency.