On 22 March 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency published the results of its March 2024 meeting. CHMP adopted a positive opinion for the following Sandoz and Celltrion biosimilars:
- Sandoz’s denosumab biosimilars, Jubbonti® and Wyost®, for all indications of Amgen’s Prolia® and Xgeva® respectively. Jubbonti® and Wyost® were approved in the US on 5 March 2024.
- Celltrion’s Omlyclo® (omalizumab), biosimilar to Novartis’ Xolair®. Celltrion submitted an A-BLA in the US for its omalizumab bioximilar (CT-P39) earlier this month.
Other positive opinions adopted by CHMP include:
- Outlook Therapeutics’ LytenavaTM (bevacizumab-vikg) for wet AMD. If approved, LytenavaTM will be the first available on-label ophthalmic formulation of bevacizumab in the EU (or US).
- Novo Nordisk’s diabetes treatment, Awiqli® (insulin icodec), a long-acting basal insulin given subcutaneously once a week.
An indication extension was recommended for UCB’s previously EU-approved Bimzelx® (bimekizumab) for the treatment of hidradenitis suppurativa.