Last update: 11 December 2020
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 originator product, Eli Lilly’s Forteo/Forsteo (teriparatide), was approved by the US Food and Drug Administration (FDA) in November 2002 and by the European Medicines Agency (EMA) in June 2003 [1]. Forteo/Forsteo had worldwide sales of US$1.6 billion in 2018, before the advent of biosimilars.
The patents on Forteo/Forsteo expired in the US and in Europe in August 2019 [1]. Some of the teriparatide biosimilars and non-originator biologicals* approved or in development are presented in Table 1.
| Table 1: Biosimilars and non-originator biologicals* of teriparatide approved or in development
|
| Company name, Country
|
Product name
|
Stage of development
|
| Biosidus, Argentina*
|
Osteofortil
|
Medicamento biológico similar approved in Argentina
|
| Cadila Healthcare, India*
|
Teriparatide
|
‘Similar biologic’ approved in India in August 2012 [2]
|
| NuPTH
|
Launched in India in October 2020 [3]
|
| EuroGenerics Holdings, The Netherlands
|
Qutavina
|
Approved by EMA in June 2020 [4]
|
| Gedeon Richter/Mochida Pharmaceutical/Daewon Pharmaceutical, Hungary/Japan/ South Korea
|
Terrosa
|
Approved by EC on 4 January 2017 [5]. In-licensed by Mochida for Japanese market. Launched in Europe in August 2019 [6]. Approved by Korean MFDS in November 2019 [7].Launched in Korea in June 2020 [8].
|
| Intas Pharmaceuticals, India*
|
Teriparatide
|
‘Similar biologic’ approved in India in November 2010 [2]
|
| Pfenex/Alvogen/NT Pharma [6], USA/China*
|
PF708
|
Agreements to grant exclusive commercialization rights with NT Pharma in April 2018 and with Alvogen in June 2018 [9]. Approved by FDA in October 2019 [10].
|
| Stada Arzneimittel, Germany
|
Movymia
|
Approved by EC on 17 January 2017 [5]
|
| Theramex Ireland
|
Livogiva
|
Approved by EMA in June 2020 [4]
|
| USV, India*
|
Teriparatide
|
‘Similar biologic’ approved in India in August 2012 [2]
|
EC: European Commission; EMA: European Medicines Agency; EU: European Union; FDA: US Food and Drug Administration; MFDS: Korea’s Ministry of Food and Drug Safety.
*See editor’s comment
|
The teriparatide biosimilars Livogiva and Qutavina are produced by Theramex Ireland and EuroGenerics Holdings. The CHMP has recommended that the products be approved for the treatment of osteoporosis [4].
There are already two teriparatide biosimilars approved for use in the European Union. Stada Arzneimittel’s Movymia and Gedeon Richter’s Terrosa both received EC approval in January 2017 [5].
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted ‘medicamentos biológicos similares’ approved in Argentina, ‘copy biologicals’ approved in China, and ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
Related articles
Biosimilars of somatropin
Biosimilars of denosumab
References
1. 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
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. Cadila launches two new similar biologics in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Cadila-launches-two-new-similar-biologics-in-India
4. GaBI Online - Generics and Biosimilars Initiative. EMA approves bevacizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-bevacizumab-and-teriparatide-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6 GaBI Online - Generics and Biosimilars Initiative. Teriparatide biosimilar Terrosa launched in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Teriparatide-biosimilar-Terrosa-launched-in-Europe
7. GaBI Online - Generics and Biosimilars Initiative. Teriparatide biosimilar Terossa approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Teriparatide-biosimilar-Terossa-approved-in-South-Korea
8. GaBI Online - Generics and Biosimilars Initiative. Daewon launches teriparatide biosimilar in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Daewon-launches-teriparatide-biosimilar-in-South-Korea
9. GaBI Online - Generics and Biosimilars Initiative. Pfenex makes biosimilar deals with Alvogen and NT Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11].
www.gabionline.net/Pharma-News/Pfenex-makes-biosimilar-deals-with-Alvogen-and-NT-Pharma
10. GaBI Online - Generics and Biosimilars Initiative. FDA approves Pfenex’s follow-on teriparatide product [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-Pfenex-s-follow-on-teriparatide-product
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Source: Eli Lilly,EMA, US FDA
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