EMA Approves Two Biosimilars and Two Generic Drugs

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The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

The European Medicines Agency announced on February 1, 2019 that its human medicines committee (CHMP) recommended six drugs for approval and gave a negative opinion on Doxolipad (doxorubicin). The committee also extended indications for nine medications.

The positive opinions granted by CHMP included migraine treatment Ajovy (fremanezumab) and Vizimpro (dacomitinib) for the treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor activating mutations.

Biosimilars Idacio (adalimumab) and Kromeya (adalimumab) were also approved for certain inflammatory and autoimmune disorders. CHMP also approved generic drugs Atazanavir Krka (atazanavir), for the treatment of HIV-1 infection in adults and children six years of age and older, and Febuxostat Krka (febuxostat), for the prevention and treatment of hyperuricaemia.


The committee also extended therapeutic indications for Edistride, Forxiga, Hemlibra, Keytruda, Mabthera, Maviret, Orencia, Praluent and Tecentriq.

Source: EMA