Posted by Michael Wonder on 15 Nov 2016
STADA receives “positive opinion” from the EMA for teriparatide biosimilar
14 November 2016 - As expected and within the scope of the current EU-wide approval procedure, STADA Arzneimittel AG on November 11 received a so-called “positive opinion” for the biosimilar teriparatide from the responsible EU approval authority, EMA.
In line with the application, 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.
