EMA announces positive opinion for SB15 (OPUVIZ, Samsung Bioepis and Biogen)

In the next step, the European Commission will decide whether to grant the marketing authorisation for SB15. Image credit: ©ArtJazz – stock.adobe.com

On Friday, Samsung Bioepis Co., Ltd., based in Korea, and Biogen Inc, based in Massachusetts, announced the European Medicines Agency (EMA) issued a positive opinion for SB15 40mg/mL (OPUVIZ). The Committee for Medicinal Products for Human Use (CHMP) issued its recommendation for marketing authorisation, which will be referred to the European Commission for approval. The CHMP’s positive opinion was based on a totality of evidence surrounding SB15, including both clinical and non-clinical data, according to a press release.1

According to Samsung Bioepis and Biogen, SB15 has been recommended for approval in adult patients for the treatment of neovascular (wet) age related macular degeneration, visual impairment due to macular oedema secondary to branch or central retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation.

A randomised, double-masked, parallel group, multicentre Phase 3 study demonstrated equivalent efficacy, as well as comparable safety, immunogenicity and phamacokinetics between SB15 and the reference product, aflibercept. These results were assessed at weei 8, the 32-week interim period and at 56 weeks.

This is the companies' second ophthalmology biosimilar to receive the recommendation. SB11 (BYOOVIZ, biosimilar ranibizumab), was awarded marketing authorisation in 2021. Samsung Bioepis and Biogen announced a commercialisation for two biosimilar candidates, SB11 and SB15, in November 2019.

Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, called the CHMP opinion a significant milestone. “The positive opinion underscores not only our commitment to innovation but also ensuring access so that more patients can benefit from biologic therapies,” she said. “We will continue our work to transform the way biologic therapies are brought to patients and enhance the lives of patients, through our pioneering and innovative use of science and technology.”

The European Commission will decide whether to grant the marketing authorisation for SB15 following the CHMP's ruling.

Reference

1. Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ. Press release. Biogen. Published 20 September, 2024. Accessed 20 September, 2024. https://investors.biogen.com/news-releases/news-release-details/samsung-bioepis-and-biogen-receive-positive-chmp-opinion-0