INCHEON, Korea and CAMBRIDGE, MA, USA I June 25, 2021 I Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today 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®1 (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 oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular odemea 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 becoming the first biosimilar of ranibizumab to be recommended for approval in Europe. This marks an important milestone for our company, as this is one step forward to expanding patient access to treatments for retinal vascular disorders,” said Kyung-Ah Kim, Senior Vice President and Development Division 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 a 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 and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and SB15 (aflibercept), in the U.S., Canada, Europe, Japan and Australia.

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

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology and endocrinology. Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – TwitterLinkedInFacebookYouTube.

SOURCE: Samsung Bioepis