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Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

Published on 28/06/21 at 09:39am

Samsung Bioepis and Biogen have announced that the EMA’s 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.

The positive CHMP opinion has recommended Byooviz for approval for the treatment of neovascular age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization (CNV) in the European Union.

Ranibizumab is an anti-VEGF (vascular endothelial growth factor) for retinal vascular disorders, which are a leading cause of blindness.

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

Kyung-Ah Kim, Senior Vice President and Development Division Leader at Samsung Bioepis, said: “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.”

The CHMP’s opinion was based upon a Phase III study that demonstrated equivalence in efficacy for both primary endpoints.

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

Ian Henshaw, Global Head of Biosimilars at Biogen, said: “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.

“Biosimilars could help broaden access and offer significant healthcare savings through the treatment of these complex and often debilitating ophthalmic diseases.”

Kat Jenkins

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