Biosimilars of teriparatide Posted 03/03/2017

Last update: 4 March 2017

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$1.3 billion in 2015.

The patents on Forteo/Forsteo expire in the US in December 2018 and expired in Europe in June 2013 [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 infliximab approved or in development

Company name, Country

Product name

Stage of development

Cadila Healthcare, India*

Teriparatide

‘Similar biologic’ approved in India in August 2012 [2]

Gedeon Richter, Hungary; Mochida Pharmaceutical, Japan

Terrosa

Approved by EMA in November 2016 [3]. In-licensed by Mochida for Japanese market

Intas Pharmaceuticals

Teriparatide

‘Similar biologic’ approved in India in November 2010 [2]

Pfenex, USA

PF708

Biosimillar candidate undergoing comparative clinical study

Stada Arzneimittel, Germany

 

Movymia

Approved by EMA in November 2016 [3]

USV

Teriparatide

‘Similar biologic’ approved in India in August 2012 [2]

EMA: European Medicines Agency; EU: European Union; FDA: US Food and Drug Administration.

*See editor’s comment.

EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for the teriparatide biosimilars, Movymia and Terrosa, produced by German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter), respectively [3].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
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. EMA approves biosimilars of insulin glargine and teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilars-of-insulin-glargine-and-teriparatide

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Source: Eli Lilly,EMA, US FDA

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