Biosimilar BYOOVIZ™ now reimbursed in Quebec to treat serious retinal disorders
- First provincial listing of anti-VEGF ranibizumab biosimilar brings cost-effective new option to patients and helps support healthcare system sustainability
Toronto, Ontario Canada – July 6, 2023 – Biogen Canada Inc. is pleased to announce that Quebec has become the first province to reimburse PrBYOOVIZ™ (ranibizumab injection), an anti-vascular endothelial growth factor (anti-VEGF) biosimilar therapy for certain eye conditions affecting the retina.
BYOOVIZ, which references PrLUCENTIS®, is the first biosimilar available in Canada to treat retinal vascular disorders including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema. Like all biosimilars, BYOOVIZ was evaluated using the same rigorous regulatory standards as all other biologic drugs and was determined by Health Canada to have no significant differences in quality, efficacy and safety compared to its reference biologic drug, LUCENTIS1.
Reimbursement in Quebec follows a positive reimbursement recommendation by the Institut national d'excellence en santé et en services sociaux (INESSS) in December 2022 and the successful completion in May 2023 of the pan-Canadian Pharmaceutical Alliance (pCPA) negotiation process for BYOOVIZ2,3.
“We are pleased that BYOOVIZ has been recognized for the important value an additional anti-VEGF treatment brings to patients, physicians and the healthcare system as a whole,” said Eric Tse, General Manager at Biogen Canada. “Our experience with biologic therapies runs deep and is part of our commitment to advance patient care with life-changing therapies. We are proud to provide a high quality, cost-effective treatment option for retinal vascular disorders, and look forward to continuing to work with the other provinces to provide greater public formulary access to BYOOVIZ across the country.”
The reimbursement criteria for BYOOVIZ in Quebec can be found by following this link: Quebec Public Prescription Drug Insurance Plan formulary list.
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 vision4.
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 drug5,6.
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 chorioretinaopathy4.
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 a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and developed the first approved treatment to address a defining pathology of Alzheimer’s disease. Biogen is also commercializing biosimilars and focusing on advancing one of the industry’s most diversified pipelines 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 Best Workplace™ for Giving Back and Hybrid Work. To learn more, please visit www.biogen.ca.
1. Health Canada. Biosimilar biologic drugs in Canada: Fact Sheet. Available at: Fact-Sheet-EN-2019-08-23.pdf (canada.ca).
2. Institut national d'excellence en santé et en services sociaux. Extrait de l’avis au Ministre sur Byooviz. Available at: https://www.inesss.qc.ca/thematiques/medicaments/medicaments-evaluation-aux-fins-dinscription/extrait-davis-au-ministre/byooviz-6450.html?DemandePluginController%5Bonglet%5D=2&cHash=25986745f329a5020443ba1398131e4b.
3. pan Canadian Pharmaceutical Alliance. Byooviz (ranibizumab) Available at: https://www.pcpacanada.ca/negotiation/22008.
4. BYOOVIZ™ Canadian Product Monograph. Available at: www.biogen.ca/products/BYOOVIZ_PM_EN.
5. 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.
6. 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.
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