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Teriparatide biosimilar Terrosa launched in Europe Posted 06/09/2019

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference product in August 2019.

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 European Commission (EC) approved Terrosa in January 2017, following the adoption of a positive opinion by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in November 2016 [1]. The EMA’s CHMP concluded that the data derived from the comprehensive physico-chemical and biological characterization, in vivo non-clinical studies and the clinical trial, constituting the development programme of Terrosa had demonstrated biosimilarity with the originator product Forsteo (teriparatide). The EC approval of Terrosa applies to all 28 European Union Member States and European Economic Area (EEA) Member States.

Terrosa has been approved in adults for the same indications as Eli Lilly’s Forsteo, i.e. used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.

Forteo/Forsteo had worldwide sales of US$1.6 billion in 2018. The patents on Forteo/Forsteo expired in Europe and the US in August 2019 [2].

References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilars of insulin glargine and teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 6]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilars-of-insulin-glargine-and-teriparatide
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007

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Source: Gedeon Richter

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