medwireNews: The EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of a teriparatide biosimilar for the treatment of osteoporosis.
This decision is based on data showing that the biosimilar – marketed as Sondelbay – is highly similar to the teriparatide reference product, which was approved in the European Union in 2003. Teriparatide is recommended for the treatment of osteoporosis in postmenopausal women, in men at increased risk for fractures, and in men and women at increased risk for fractures due to long-term glucocorticoid treatment.
Teriparatide is a parathyroid hormone treatment consisting of the active aminoterminal fragment, and has an anabolic effect on bone.
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