Posted by Michael Wonder on 28 Jan 2017
Meeting highlights from the CHMP 23-26 January 2017 meeting
27 January 2017 - The EMA’s CHMP recommended eight medicines for approval at its January meeting.
The Committee recommended granting a marketing authorisation for Xeljanz (tofacitinib citrate) for the treatment of rheumatoid arthritis.
One hybrid medicine, Jylamvo (methotrexate) received a positive opinion for the treatment of rheumatological disorders and psoriasis, and for the maintenance treatment of acute lymphoblastic leukaemia. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
Two biosimilar medicines were recommended for approval by the Committee: Amgevita and Solymbic, both containing adalimumab.
