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 Acetate powder
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].
