EMA Recommends Two Biosimilars, One Orphan Drug, for Approval

March 23, 2018

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six drugs for approval at its March 2018 meeting. Included in the recommendations were two biosimilars and two generic drugs, and orphan drug Rubraca (rucaparib), for the treatment of relapsed or progressive ovarian cancer, was grated conditional marketing authorization.

CHMP gave positive opinions for Pemetrexed Krka (pemetrexed), which is used to treat malignant pleural mesothelioma and non-small cell lung cancer, and Prasugrel Mylan (prasugrel), which is used to prevent atherothrombotic events. The recommended biosimilars were Kanjinti (trastuzumab), used to treat breast and gastric cancer, and Zessly (infliximab), which is used to treat rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. The committee also recommended Juluca (dolutegravir/rilpivirine) for the treatment of HIV infection.

Source: EMA