Mylan Launches Humira Biosimilar in Europe

On Oct. 19, 2018, Mylan announced the launch of Hulio (adalimumab), a biosimilar to AbbVie's blockbuster Humira (adalimumab), across major markets in Europe. Hulio is approved for all adalimumab indications. Humira is AbbVie’s top-selling product, with $18.4 billion in 2017 sales. In Europe, brand sales of the product totaled $4.3 billion for the 12 months ending July 31, 2018, according to IQVIA.

"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,” said Mylan President Rajiv Malik in a company press release. “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 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," said Dr. Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics president and CEO, in the press release. "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 in 2018. 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, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis. It is also approved for pediatric indications in 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).

Source: Mylan