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CHMP recommends approval of Qutavina teriparatide biosimilar for osteoporosis.- EuroGenerics Holdings
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Qutavina (teriparatide), from EuroGenerics Holdings, intended for the treatment of osteoporosis. Qutavina will be available as a solution for injection (20 micrograms/80 microlitres). Qutavina is a biosimilar medicinal product. It is highly similar to the reference product Forsteo (teriparatide), which was authorised in the EU on 10 June 2003. Data show that Qutavina has comparable quality, safety and efficacy to Forsteo.