Health Canada Approves Samsung Bioepis and Biogen's BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (Ranibizumab)

• BYOOVIZ™ becomes the first Lucentis^® biosimilar to be approved in Canada following its approval in Europe and the United States in 2021

INCHEON, Korea and TORONTO, March 10, 2022 /CNW/ - Samsung Bioepis Co., Ltd., and Biogen Canada Inc. today announced that Health Canada has approved BYOOVIZ™ – a biosimilar referencing LUCENTIS^®1 (ranibizumab) – for the treatment of neovascular (wet) age-related macular degeneration (AMD); visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM, including but not limited to angioid streaks, post-inflammatory retinochoroidopathy, central serous choriorentinopathy or idiopathic chorioretinaopathy.

Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders² including AMD that affects nearly 2 million Canadians and accounts for 90 percent of new cases of legal blindness in Canada.³

Health Canada granted a Notice of Compliance (NOC) for BYOOVIZ™ on March 8, making it the first and only ranibizumab biosimilar to receive regulatory approval in Canada to date. A biosimilar is a biologic drug that is highly similar to an already authorized biologic drug, known as the reference biologic drug, and has no clinically meaningful differences in efficacy and safety from the reference product authorized for sale.⁴

"We are pleased to have achieved a key milestone with Health Canada's regulatory approval of our ranibizumab biosimilar," said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. "The approval is part of our commitment to providing a treatment option for patients with retinal vascular disorders in Canada."

"With an estimated eight million Canadians at risk of losing their sight due to an eye disease and AMD the leading cause of vision loss in those over 50, we are excited to be part of this important milestone in providing new treatment options for those affected by debilitating ophthalmic diseases like retinal vascular disorders," said Eric Tse, General Manager at Biogen Canada. "This is an important first step for Biogen's biosimilars franchise in Canada. We believe biosimilars are a key step towards providing more Canadians with access to quality treatment, while offering significant savings to our healthcare system."

The Health Canada approval was based on a totality of evidence including qualilty, non-clinical data, and clinical data. In a randomized, double-masked, parallel group, multicentre Phase 3 study, the efficacy, safety, pharmacokinetics, and immunogenicity of ranibizumab were compared to the reference product in patients with wet AMD and were found to be similar.

Prior to this approval in Canada, BYOOVIZ™ became the first ophthalmology biosimilar approved in the United States on September 17, 2021, and was also approved in Europe, including 27 European Union (EU) member countries on August 18, 2021, and the United Kingdom on August 31, 2021.

In November 2019, Samsung Bioepis signed a commercialization agreement with Biogen Inc. for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept). Under the agreement, Biogen is responsible for commercialization of SB11 and SB15 in the United States, Canada, Europe, Japan and Australia.

BYOOVIZ™ is Samsung Bioepis' sixth biosimilar approved in Canada after receiving the company's approval of BRENZYS^® (etanercept) in August 2016, RENFLEXIS^® (infliximab) in December 2017, HADLIMA^® (adalimumab) in May 2018, AYBINTIO^® (bevacizumab) in November 2021, and ONTRUZANT^® (trastuzumab) in February 2022, and Biogen Canada's first approved biosimilar.

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, endocrinology and gastroenterology. For more information, please visit: www.samsungbioepis.com and follow us on social media – Twitter, LinkedIn.

About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological 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, Sir 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, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

Since 1998, Biogen Canada has been delivering life-changing medicines and services that support unmet treatment needs and the lives of Canadians affected by neurological conditions. As a company that founds its culture on principles of equity, diversity and inclusion, Biogen Canada is proud to have been named a Top 50 Best Workplace™ in the country and Healthcare, as well as a Best Workplace™ for Inclusion, Women, Giving Back, and Hybrid Work. To learn more, please visit www.biogen.ca.

References:

1.	Lucentis is a registered trademark of Genentech, Inc.
2.	CADTH Therapeutic Report. Anti-Vascular Endothelial Growth Factor Drugs for the Treatment of Retinal Conditions Recommendations Report. May 2016. Available at https://www.cadth.ca/sites/default/files/pdf/TR0009_Anti-VEGFs_Recs_Report.pdf. Accessed in Jan, 2022
3.	Canadian Ophthalmological Society News Release. Feb 2021. Available at https://www.cos-sco.ca/amd-awareness-month-sheds-light-on-the-leading-cause-of-severe-vision-loss-in-older-adults/ Accessed in Jan 2022.
4.	Health Canada Biosimilars Fact Sheet. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html. Accessed in Jan 2022.

SOURCE Biogen Canada

MEDIA CONTACTS: Biogen Canada, Marija Mandic, + 1 416 234 7901, [email protected]; Samsung Bioepis, Jane Chung, [email protected]