Public reimbursement for biosimilar BYOOVIZ™ to treat serious retinal disorders now secured in four provinces and two national benefits programs

• Ontario and New Brunswick among latest jurisdictions to reimburse biosimilar of anti-VEGF ranibizumab, improving patient access to treatment for certain retinal diseases

TORONTO, Oct. 4, 2023 /CNW/ - Biogen Canada Inc. is pleased to announce that Ontario, New Brunswick, and Prince Edward Island have joined Quebec to reimburse ^PrBYOOVIZ™ (ranibizumab injection), an anti-vascular endothelial growth factor (anti-VEGF) biosimilar therapy for certain eye conditions affecting the retina. In addition, BYOOVIZ is now covered by the Non-Insured Health Benefits (NIHB) and Veterans Affairs Canada (VAC) Health Care Benefits programs.

BYOOVIZ is the first biosimilar available in Canada that references ^PrLUCENTIS^® to treat retinal vascular disorders including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema. This provides an additional option for retinal disease management with anti-VEGF therapies, which have become a therapeutic mainstay for various retinal vascular disorders¹.

With no significant differences in quality, efficacy and safety as their reference biologic drugs, biosimilars offer important, more cost-effective treatment options that can respond to patient needs². Public reimbursement of biosimilars helps create opportunities for savings and resource reallocation to other areas in the healthcare system.

"We're excited to see the expansion of patient access to BYOOVIZ and are very pleased that more jurisdictions are incorporating this additional anti-VEGF option into their publicly administered programs," said Eric Tse, General Manager at Biogen Canada. "We believe this holds great potential for patients, physicians and the healthcare system, and With World Sight Day approaching, are particularly delighted we are able to meet patients' needs with a treatment option that helps make vision care more accessible."

The reimbursement criteria for BYOOVIZ for each jurisdiction providing public access through its public drug benefit plan can be found by following the links below:

Ontario
New Brunswick
Prince Edward Island
Quebec
Non-Insured Health Benefits Program Drug Benefits List
Veterans Affairs Canada Treatment Benefits List

About BYOOVIZ
Administered into the eye by intravitreal injection, BYOOVIZ treats damage to the retina (the light-sensitive back part of the eye) and acts to stop the growth and leakage of new blood vessels in the eye, abnormal processes that contribute to several eye diseases that can cause decreased vision³.

BYOOVIZ received marketing authorization from Health Canada in 2022 after meeting quality, efficacy and safety criteria and having demonstrated similar efficacy and a comparable safety profile to its reference biologic drug^3,4,5.

BYOOVIZ is indicated 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 chorioretinaopathy³.

Biogen markets and sells BYOOVIZ pursuant to an agreement with Samsung Bioepis, the marketing authorization holder for the product. The Biogen and Samsung Bioepis commercialization agreement includes two ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar candidate referencing EYLEA® (aflibercept). As part of the agreement, Samsung Bioepis is responsible for development, regulatory registration, and manufacture of the products, while Biogen is responsible for commercialization. 

About Biogen
Founded in 1978, Biogen is a leading global biotechnology company that has pioneered multiple breakthrough innovations including a broad portfolio of medicines to treat multiple sclerosis, the first approved treatment for spinal muscular atrophy, and two co-developed treatments to address a defining pathology of Alzheimer's disease. Biogen is advancing a pipeline of potential novel therapies across neurology, neuropsychiatry, specialized immunology, and rare diseases and remains acutely focused on its purpose of serving humanity through science while advancing a healthier, more sustainable, and equitable world. To learn more about Biogen Canada, please visit www.biogen.ca.

References:
1.	Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
2.	Health Canada. Biosimilar biologic drugs in Canada: Fact Sheet. Available at: Fact-Sheet-EN-2019-08-23.pdf (canada.ca).
3.	BYOOVIZ™ Canadian Product Monograph. Available at: www.biogen.ca/products/BYOOVIZ_PM_EN
4.	Woo SJ, Veith M, Hamouz J, et al. Efficacy and safety of a proposed ranibizumab biosimilar product vs a reference ranibizumab product for patients with neovascular age-related macular degeneration: a randomized clinical trial. JAMA Ophthalmol. 2021;139(1):68-76.
5.	Bressler NM, Veith M, Hamouz J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. Br J Ophthalmol. 2021;bjophthalmol-2021-319637. doi:10.1136/bjophthalmol-2021-319637

LUCENTIS^® is a registered trademark of Genentech Inc.
EYLEA® is a registered trademark of Regeneron Pharmaceuticals

SOURCE Biogen Canada

MEDIA CONTACT: Michael Oreskovich, Communications Specialist, [phone], [email protected]