News
CHMP recommends Hukyndra a biosimilar to Humira for inflammatory and autoimmune disorders.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hukyndra, intended for the treatment of certain inflammatory and autoimmune disorders.
The applicant for this medicinal product is STADA Arzneimittel AG. Hukyndra 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. Data show that Hukyndra has comparable quality, safety and efficacy to Humira.
Condition: RA/AnkSpon/Crohns/UC/PsA/Ps
Type: drug
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