Teriparatide biosimilar Terossa approved in South Korea

Biosimilars/News | Posted 24/01/2020 post-comment0 Post your comment

South Korea-based Daewon Pharmaceutical has obtained regulatory approval to begin marketing and selling its teriparatide biosimilar in Korea.

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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.

South Korea’s drug regulator, the Ministry of Food and Drug Safety (MFDS), granted marketing approval for Terrosa (teriparatide) in November 2019.

Daewon Pharmaceutical signed a licensing agreement with Richter-Helm BioTec (Hungary-based Gedeon Richter and Germany’s Helm) to sell osteoporosis treatment Terrosa in South Korea in February 2017.

The originator product, Eli Lilly’s Forteo/Forsteo (teriparatide), had worldwide sales of US$1.6 billion in 2018, before the advent of biosimilars [1]. The patents on Forteo/Forsteo expired in the US and in Europe in August 2019 [2].

Terossa is the first teriparatide biosimilar to receive regulatory approval in South Korea. It is also the first biosimilar approval for Daewon Pharmaceutical. Terossa also received approval in Europe in January 2017 [3].

Daewon Pharmaceutical’s CEO, Choi Tae-hong, said that ‘with the increasing proportion of parathyroid hormone drugs in the global market, the company expects that the drug will have a highly competitive value in Korea as the nation’s first biosimilar licensed with teriparatide as the main ingredient’.

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-teriparatide
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jan 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Korea Biomedical Review, The Korea Herald

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