Hulio, a biosimilar to Humira (adalimumab), has been given a favorable opinion by the Committee for Medicinal Products for Human Use (CHMP) to treat a number of inflammatory diseases in the EU — including Crohn’s disease and ulcerative colitis, the product’s manufacturers, Mylan and Fujifilm Kyowa Kirin Biologics, announced in a press release.
CHMP is a branch of the European Medicines Agency, the regulatory agency for medical treatments and products in the 28-member EU plus Norway, Iceland and Liechtenstein. A final decision by the European Commission is expected in October.
Hulio, if approved for marketing by the EC, will be available as a 40mg solution for injection, CHMP said in a report detailing its opinion.
A biosimilar is a medical product that has identical properties to the original but is manufactured by a different company. Based on the original’s “innovator” products, biosimilars are approved and can be produced after original company’s patent expires.
Humira blocks the activity of tumor necrosis factor (TNF) – an inflammatory molecule that plays a significant role in several autoimmune diseases. Hulio is part of an expected wave of Humira biosimilars in Europe.
CHMP’s positive opinion follows the company’s filling for a marketing authorization application of Hulio for several indications that mirror those given to Humira. In addition to Crohn’s disease and ulcerative colitis, these include rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, and uveitis.
Additionally, CHMP recommend that Hulio also be approved for pediatric inflammatory diseases such as polyarticular juvenile idiopathic arthritis (indicated for 2 years of age and older), enthesitis-related arthritis (age 6 years and older), plaque psoriasis (age 4 years and older), Crohn’s (age 6 and older), hidradenitis suppurativa (age 12 and older) and uveitis (age 2 and older).
CHMP also reported that its opinion was based on data showing the chemical similarity of Hulio to Humira, and preclinical and clinical studies supporting Hulio was an appropriate biosimilar to Humira.
In particular, Fujifilm Kyowa Kirin Biologics conducted the ARABESC Phase 3 clinical study (NCT02260791), which showed no significant differences with regard to multiple parameters including safety, efficacy and immunogenicity (an ability to incite an immune reaction) with use of Hulio compared to Humira in patients with rheumatoid arthritis.
Humira, by AbbVie, was initially approved in the U.S. in 2002, and in the EU in 2003. Its original U.S. patent expired in December 2016, but numerous additional patents have been awarded covering its formulation and manufacturing methods that extent rights into the 2020s, according to published reports.
Fujifilm Kyowa Kirin Biologics granted an exclusive license to Mylan to commercialize Hulio in Europe.