Health Canada Approves First Ranibizumab Biosimilar

Health Canada has approved Byooviz, a biosimilar referencing Lucentis (ranibizumab), for the treatment for several ophthalmic conditions. Byooviz represents the first ranibizumab biosimilar to be approved for the Canadian market.

The biosimilar was developed through a commercialization agreement between Samsung Bioepis and Biogen Canada and is indicated for the treatment of:

• neovascular (wet) age-related macular degeneration (AMD)
• visual impairment due to diabetic macular edema
• macular edema secondary to retinal vein occlusion
• choroidal neovascularization secondary to pathologic myopia (PM)
• choroidal neovascularization secondary to ocular conditions other than AMD or PM

“We are pleased to have achieved a key milestone with Health Canada’s regulatory approval of our ranibizumab biosimilar….The approval is part of our commitment to providing a treatment option for patients with retinal vascular disorders in Canada,” said Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, a company statement.

The news comes just over a month after Health Canada approved Ontruzant, a trastuzumab biosimilar referencing Herceptin, also developed by Samsung Bioepis.

Byooviz is the sixth biosimilar developed by Samsung Bioepis to be approved in Canada, following Ontruzant, Brenzys (etanercept) in August 2016, Renflexis (infliximab) in December 2017, Hadlima (adalimumab) in May 2018, and Aybintio (bevacizumab) in November 2021. Brenzys references Enbrel, Renflexis references Rituxan, Hadlima and Simlandi are biosimilars for Humira, and Aybintio references Avastin.

Byooviz was also the first biosimilar for Biogen to receive approval in Canada.

Ranibizumab is an anti-vascular endothelial growth factor therapy for ophthalmic conditions related to the retina, such as AMD, which impacts nearly 2 million people in Canada and accounts for 90% of new cases of legal blindness in the country.

“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…. We believe biosimilars are a key step towards providing more Canadians with access to quality treatment, while offering significant savings to our healthcare system,” said Eric Tse, general manager at Biogen Canada.

The approval was based on nonclinical data and data from randomized, double-masked, parallel group, multicenter phase 3 study that demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity of the biosimilar with the reference product in patients with wet AMD.

Previously, Byooviz became the first FDA-approved ophthalmology biosimilar in September 2021 and was approved in August 2021 for marketing authorization in the European Union and the United Kingdom.

In November 2019, Samsung Bioepis and Biogen entered into a commercialization agreement for 2 ophthalmology biosimilars, including Byooviz (SB11) and SB15, an aflibercept biosimilar referencing Eylea. As part of the agreement, Samsung Bioepis oversees the manufacturing and development of the biosimilars and Biogen is in charge of commercialization in the United States, Canada, the European Union, the United Kingdom, Japan, and Australia.

In January 2022, Biogen sold its full ownership stake in Samsung Bioepis for $2.3 billion after it increased it from 15% to 50% in 2012. Under the agreement, Biogen received $1 billion in cash at closing, an $812.5 million payment at the first anniversary of the transaction close, and a $437.5 million at the second anniversary. Biogen is also eligible to receive up to $50 million upon achievement of certain commercial milestones.