Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, Byooviz

Samsung Bioepis Biogen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Byooviz, a biosimilar candidate referencing Lucentis(ranibizumab), also known as SB11. Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness. Byooviz has been recommended for approval for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV) in the European Union (EU).

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will decide whether to grant a marketing authorization for Byooviz. If a marketing authorization is granted by the EC, Byooviz would be added to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in Europe: Benepali, Imraldi, and Flixabi.

“We are very proud to see Byooviz become the first biosimilar of ranibizumab to be recommended for approval in Europe. This marks another milestone for our company, as this is one step forward to expanding the patient access to treatments for retinal vascular disorders,” said Kyung-Ah Kim, Senior Vice President and Development Division Leader at Samsung Bioepis. “We will continue our efforts to develop and deliver high-quality and proven biologic medicines to more patients and healthcare systems in Europe.”

“Retinal vascular disorders affect millions of people, and we believe Byooviz has the potential to be a meaningful therapeutic offering for patients living with these disorders,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.”

This positive CHMP opinion on Byooviz was based on phase 3 clinical study that demonstrated equivalence in efficacy for both primary endpoints. The adjusted treatment differences between groups were within predefined equivalence margins for mean changes from baseline in both best corrected visual acuity (BCVA) and in central subfield thickness (CST). The improvements in the primary efficacy outcomes remained stable and appeared comparable between treatment groups at all time points up to week 52.

In November 2019, Samsung Bioepis announced that it entered into a new commercialization agreement with Biogen for two ophthalmology biosimilar candidates, Byooviz (SB11, ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan and Australia.

Additionally, the Biologics License Application (BLA) for SB11 was accepted for review by the U.S. Food and Drug Administration (FDA) in November 2020.

Lucentis is registered trademark of Genentech, Inc.