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 Committee for Medicinal Products for Human Use (CHMP), which concluded that the development programme including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product.
“The EC’s approval of Hulio marks a significant milestone. In cooperating with Mylan, we continue to commit all efforts to bring high quality and affordable biosimilars to patients throughout European countries,” said Dr Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics president and chief executive.
“Biosimilars represent a huge opportunity in Europe to drive better patient access through high quality, value medications that support healthcare systems across the region to deliver ongoing excellent care in the face of aging populations and increasingly stretched resources,” added Mylan Europe president Jacek Glinka.
Mylan said it plans to launch Hulio across various markets in Europe after October 16.
Humira, an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases. Biosimilar versions are expected to be significantly cheaper, and thus have the potential to generate substantial savings for healthcare providers.