Mylan launches Hulio, a biosimilar to Humira, across major European markets

Mylan has officially launched Hulio, its biosimilar to AbbVie’s Humira (adalimumab), across major European markets. This launch follows the European Commission’s recent approval of Hulio for all indications of the reference product.

Hulio will be accessible to patients in Europe as soon as possible, thanks to a partnership between Mylan and Fujifilm Kyowa Kirin Biologics. The two companies, who entered into a commercialization agreement in April, have positioned Hulio as a critical addition to the biosimilars market. Fujifilm Kyowa Kirin Biologics holds a non-exclusive, royalty-bearing license with AbbVie for the sale and use of Hulio throughout Europe, while Mylan has secured a sublicense for the Humira biosimilar.

Rajiv Malik, President of Mylan, expressed pride in the collaboration: “We’re proud of our strategic partnership with Fujifilm Kyowa Kirin Biologics and the strong collaboration of our science and technology teams to bring Hulio to market for patients. As healthcare costs continue to rise globally, biosimilars like Hulio play a crucial role in making essential medicines accessible. Hulio, being the fourth product in Mylan’s portfolio of complex generics and biosimilars launched in Europe, will significantly benefit patients suffering from chronic conditions such as autoimmune disorders.”

The European Commission’s approval of Hulio was based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). This opinion confirmed that Hulio is biosimilar to Humira, supported by a comprehensive development program that included analytical, functional, clinical, and immunogenicity data. The approval extends across all 28 European Union (EU) member states and the European Economic Area (EEA) countries of Norway, Iceland, and Liechtenstein.

Dr. Yoshifumi Torii, President and CEO of Fujifilm Kyowa Kirin Biologics, commented on the milestone: “The launch of Hulio in Europe marks a significant achievement for our scientific and development efforts in the biosimilar domain. Our partnership with Mylan has been instrumental in advancing this important product to the European market.”

Hulio is indicated for the same conditions as Humira, which include:

• In Adults: Rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis, and uveitis.
• In Children: Polyarticular juvenile idiopathic arthritis (age 2 and older), enthesitis-related arthritis (age 6 and older), plaque psoriasis (age 4 and older), Crohn’s disease (age 6 and older), hidradenitis suppurativa (age 12 and older), and uveitis (age 2 and older).

Mylan’s introduction of Hulio underscores its commitment to expanding access to high-quality, affordable treatment options across Europe.