Posted by Michael Wonder on 20 Sep 2018
EU green light for new Humira biosimilar
20 September 2018 - The European Commission has approved Mylan and Fujifilm Kyowa Kirin Biologics’ Humira biosimiar Hulio.
The decision allows use of Hulio for all of Humira’s (adalimumab) approved indications, including rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis and psoriasis.
It follows earlier backing by the CHMP, which concluded that the development programme including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product.
