European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare
The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.
Celltrion Healthcare announced, in an Aug. 19, 2022 press release, that the European Commission (EC) has approved Vegzelma (CT-P16), its biosimilar to bevacizumab referencing the European Union (EU)-approved Avastin.
The approval covers the use of Vegzelma in the treatment of European patients with 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. EC’s decision follows on from the recommendation for marketing authorization that was issued by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).
“The European Commission’s approval of Vegzelma will increase access to treatment for patients living with certain types of cancer at an affordable price,” said Kevin Byoung Seo Choi, senior vice-president and head of Marketing Division at Celltrion Healthcare, in the press release. “With proven similarities in efficacy and safety compared to the reference product Avastin, Vegzelma will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year.”
Source: Celltrion Healthcare
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
