Three more biosimilar approvals in Canada in 2023

In Canada, three biosimilars were approved in late 2023. These are, Amgen’s Wezlana (ustekinumab), JAMP/Alvotech’s Jamteki (ustekinumab), and Formycon/Polpharma Biologics/Bioeq’s Ranopto (ranibizumab).

Two ustekinumab biosimilars were approved by Health Canada before the end of 2023. On 27 December 2023, Amgen’s ustekinumab product, Wezlana, became the first biosimilar to be approved for all indications (including adult and paediatric plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis) as the originator, Stelara.

Amgen’s Wezlana has also been approved in the US as the first interchangeable ustekinumab biosimilar [1].

Health Canada’s approval for Wezlana was based on a robust comprehensive data package, which found no clinically meaningful differences in efficacy, safety and immunogenicity between Wezlana and Stelara. Wezlana is available as a subcutaneous injection, 45 mg/0.5 mL and 90 mg/mL, and as an intravenous solution, 130 mg/26 mL (5mg/mL).

Prior to this, in late November 2023, Alvotech and Jamp’s Jamteki was approved as the first biosimilar of ustekinumab in Canada for the treatment of psoriasis and psoriatic arthritis. The companies expect that the product will also be approved for all indications of the originator, Janssen’s Stelara, which include Crohn’s disease and ulcerative colitis.

Jamteki is the second biosimilar developed under the exclusive partnership between Canada-based JAMP Pharma Group and Iceland-based Alvotech; and will be available in 45 mg/0.5 mL pre-filled syringe with passive safety device for subcutaneous injection (PFS-SD) and the 90 mg/mL PFS-SD.

Both Wezlana and Jamteki were subsequently launched in March 2024. JAMP entered the biosimilars market in Canada via BioJAMP which was created in February 2022, with the first launch of adalimumab biosimilar Simlandi.

Furthermore, on 11 October 2023, Formycon, Polpharma Biologics, Bioeq AG and Teva Canada, jointly announced that Health Canada granted the ‘Notice of Compliance’ (NOC) for Ranopto/FYB201 (ranibizumab), a biosimilar to Lucentis. The product has already been approved in Europe, marketed as Ranivisio [2], the US, marketed as Cimerli (ranibizumab-eqrn) by Coherus [3], and countries of the Middle East and North Africa (MENA) region.

Ranopto is indicated for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).

Ranopto (FYB201) was developed by Bioeq, a joint venture between Formycon and Polpharma Biologics. In mid 2021, Teva Pharmaceutical entered into a strategic partnership for the exclusive commercialization of FYB201 in Canada, Europe and selected other countries [5, 6]. Commercial launch by Teva Canada Ltd is expected to start in the first quarter of 2024.

These approvals follow in line as Canada is now a country with a thriving biosimilars market; by the end of March 2024, there are 59 biosimilars approved in Canada [4].

EC approval of first ustekinumab biosimilar Uzpruvo

Canada approves five biosimilars in last seven months

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
2. GaBI Online - Generics and Biosimilars Initiative. EC approves ranibizumab biosimilar Ranivisio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/news/ec-approves-ranibizumab-biosimilar-ranivisio
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ranibizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ranibizumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-canada
5. GaBI Online - Generics and Biosimilars Initiative. Teva signs deal with Bioeq for ranibizumab biosimilar FYB201 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/pharma-news/teva-signs-deal-with-bioeq-for-ranibizumab-biosimilar-fyb201
6. GaBI Online - Generics and Biosimilars Initiative. Formycon launches biosimilar ranibizumab Ravegza in Saudi, Gedeon Richter invests [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 May 14]. Available from: www.gabionline.net/pharma-news/formycon-launches-biosimilar-ranibizumab-ravegza-in-saudi-gedeon-richter-invests

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