Mylan has launched Hulio, a biosimilar to AbbVie’s Humira (adalimumab), in major markets in Europe, a month after its approval from the European Commission for all indications of the reference product.
Hulio will be available to patients as early as possible, said Mylan, which partnered with Fujifilm Kyowa Kirin Biologics in April to commercialize the Humira biosimilar developed by the Japanese pharma company.
Fujifilm Kyowa Kirin Biologics holds a non-exclusive royalty bearing license with AbbVie for the use and sale of Hulio across European countries, while Mylan has a sublicense for the Humira biosimilar.
Rajiv Malik – President of Mylan, commenting on the launch of Hulio, said: “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 the cost of healthcare continues to rise around the world, we know the important role that biosimilars play to ensure patients can access the medicines they need.
“The availability of Hulio, the fourth product in the area of complex generics and biosimilars that Mylan is bringing to market in Europe, will positively impact the lives of patients in Europe suffering from chronic diseases such as autoimmune disorders. We look forward to continuing our leadership in bringing high quality, more affordable biosimilar products to market around the world.”
The EC approval of Hulio was driven based on the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP), which came to the conclusion that the development program including analytical, functional, clinical and immunogenicity data showed biosimilarity with the reference product Humira.
The Hulio EC approval covers all 28 European Union (EU) member nations along with the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.
Commenting on the launch of Hulio, Dr. Yoshifumi Torii – President and CEO of Fujifilm Kyowa Kirin Biologics, said: “The availability of Hulio in Europe represents an important milestone, signifying our commitment to building and executing on robust scientific programs around our portfolio of biosimilar products in development.
“We are delighted by our partnership with Mylan to bring this important product to market in Europe.”
Hulio is indicated for the same indications of its reference product Humira, including:
Hulio is indicated in adults for the treatment of:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
Hulio is indicated in children for the treatment of:
- 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)
- Uveitis (age 2 and older)