EMA Recommends Approval of Three Biosimilars

The European Medicines Agency (EMA) announced during its November 2016 meeting that the agency’s Committee for Medicinal Products for Human Use (CHMP) was recommending nine drugs for approval. Three of the approved drugs were biosimilars: Lusduna (insulin glargine) for the treatment of diabetes, and Movymia and Terrosa (both containing teriparatide) for the treatment of osteoporosis. Generics Darunavir Mylan (darunavir), for the treatment of HIV-1, and Tadalafil Generics (tadalafil), for the treatment of pulmonary arterial hypertension were also approved.

Marketing authorization approval was also given to Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients with haemophilia A; Vemlidy (tenofovir alafenamide) for the treatment of chronic hepatitis B; Fiasp (insulin aspart) for the treatment of diabetes; and Suliqua (insulin glargine/lixisenatide) for the treatment of type 2 diabetes.

Conditional marketing authorization was renewed for Translarna, a treatment for Duchenne muscular dystrophy. CHMP also recommended therapeutic indication extension for Arzerra, Caprelsa, Humira, Nimenrix, and Vimpat.