CHMP recommends Kromeya (adalimumab biosimilar) for the treatment of certain inflammatory and autoimmune disorders.- Fresenius Kabi
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Kromeya (formerly MSB 11022), intended for the treatment of certain inflammatory and autoimmune disorders. The applicant for this medicinal product is Fresenius Kabi Deutschland GmbH. Kromeya will be available as a solution for injection (40 mg in pre-filled syringe and pre-filled pen and 40 mg/0.8 ml for paediatric use). The active substance of Kromeya is adalimumab, a tumour necrosis factor alpha (TNF?) inhibitor. Kromeya is a biosimilar medicinal product. It is highly similar to the reference product Humira (adalimumab), which was authorised in the EU on 8 September 2003.
Learning Zones
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