Global pharmaceutical company Mylan announced it has initiated the commercial launch of Hulio, a biosimilar to AbbVie’s Humira (adalimumab), across major markets in Europe. The product, which is approved for all adalimumab indications, will be available to patients as soon as possible.
Mylan president Rajiv Malik comments: ‘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.’
Partnership promotes access to medicines
‘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,’ says Dr. Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics president and CEO. ‘We are delighted by our partnership with Mylan to bring this important product to market in Europe.’
Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this year. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty bearing license with AbbVie (Mylan has a sublicense) for the use and sale of Hulio in European countries. The European Commission (EC) approved Hulio in September 2018, following the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with Humira.
The EC approval of Hulio applies to all 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.
Hulio is indicated for the same indications of Humira, including:
- Rheumatoid arthritis
- Ankylosing spondylitis
- Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
- Psoriatic arthritis
- Hidradenitis suppurativa
- Crohn’s disease
- Ulcerative colitis
- Polyarticular juvenile idiopathic arthritis (age two and older)
- Enthesitis-related arthritis (age six and older)
- Plaque psoriasis (age four and older)
- Crohn’s disease (age six and older)
- Hidradenitis suppurativa (age 12 and older)
- Uveitis (age two and older)
Humira is the world’s best-selling biologic medication. It had brand sales of approximately $4.3 billion in Europe for the 12 months ending 31 July 2018, according to IQVIA.