Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Apo-teriparatide, Teva-teriparatide and Osnuvo.
The drugs are biosimilars of Eli Lilly’s Forteo/Forsteo (teriparatide), which is a recombinant form of parathyroid hormone (PTH). Teriparatide is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e. bone growing, agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women.
Avir Pharma’s Osnuvo was approved on 13 January 2020, Apotex’s Apo-teriparatide was approved on 8 May 2020 and Teva Pharmaceutical’s Teva-teriparatide was approved on 19 June 2020. All three biosimilars were approved as a solution for subcutaneous injection. Apo-teriparatide and Osnuvo were approved at a dose of 250 µg/mL, whereas Teva-teriparatide was approved at a dose of 0.25 µg/mL.
The approval of Apo-teriparatide, Teva-teriparatide and Osnuvo mark the first teriparatide biosimilars to be approved in Canada. The three products are also the first biosimilar approvals in Canada for the three companies.
Teriparatide biosimilars have also been approved in the US (Pfenex’s PF708) [1] and in Europe (Livogiva, Movymia, Qutavina and Terrosa) [2].
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| LATIN AMERICAN FORUM – Coming soon! To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America. Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM – Próximamente! Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica. Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
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