CHMP positive opinion for biosimilar teriparatide to treat osteoporosis.- Stada Arzneimittel AG + Richter-Helm BioTec.
STADA Arzneimittel AG has received a positive opinion for the biosimilar teriparatide (originator drug Forteo/Forsteo from Eli Lilly) from the Committee for Medicinal Products for Human Use (CHMP). This positive opinion covers osteoporosis in men and post-menopausal women with a high fracture risk as well as the treatment of osteoporosis in men and women with a high fracture risk associated with systematic long-term glucocorticoid therapy. An EU-wide approval of teriparatide from the EU Commission is expected in January 2017.
Comment: Stada will market the biosimilar in the EU and in nine (non-specified) non-European countries and Richter Helm Biotec will market in the CIS and " geographical Europe". The patent for Forteo/Forsteo expires at the end of December 2018.
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