Australian and Indian approval for teriparatide products

Biosimilars/News | Posted 02/04/2021 post-comment0 Post your comment

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has approved a teriparatide biosimilar and the Drug Controller General of India (DCGI) has approved a teriparatide ‘similar biologic’.

Teriparatide Forteo V21D02

Teriparatide 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.

The teriparatide biosimilar, Terrosa, which is produced by Hungary-based Gedeon Richter, was approved by Australia’s TGA on 24 November 2020 for the treatment of osteoporosis. The TGA has approved Terrosa for the treatment of osteoporosis in postmenopausal women and the treatment of primary osteoporosis in men when other agents are considered unsuitable and when there is a high risk of fractures. It is also approved for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

The approval by the TGA marks the first teriparatide biosimilar to be approved for use in Australia. Gedeon Richter also gained approval for Terrosa in Europe in January 2017 [1] and in South Korea in November 2019 [2]. And the company has in-licensed the product to Mochida for the Japanese market, who launched the biosimilar in November 2019 [3].

Enzene Biosciences (Enzyne) announced on 4 February 2021 that it had received approval for its teriparatide ‘similar biologic’ from India’s DCGI. Enzyne says that the clinical trial conducted for the teriparatide similar biologic is one of the most comprehensive trials for teriparatide in India and includes pharmacokinetics, immunogenicity and efficacy. The approved product will be launched ‘a fully compliant pen device’ and will be marketed via Alkem Laboratories and Enzyne is also exploring other potential partnering opportunities.

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Australian approved biosimilars

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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 Apr 2]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
2. GaBI Online - Generics and Biosimilars Initiative. Teriparatide biosimilar Terossa approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Teriparatide-biosimilar-Terossa-approved-in-South-Korea 
3. GaBI Online - Generics and Biosimilars Initiative. Bevacizumab and teriparatide biosimilars launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Apr 2]. Available from: www.gabionline.net/Biosimilars/News/Bevacizumab-and-teriparatide-biosimilars-launched-in-Japan

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Source: Enzyne Bioscience, TGA

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