The marketing authorization covers all indications for which Humira is approved, including inflammatory bowel disease (IBD).
The authorization comes on the heels of a positive opinion adopted by the Committee for Medicinal Products for Human Use that concluded there was sufficient data from the development program, including analytical, functional, clinical and immunogenicity (immune system reactions) data, to demonstrate Hulio’s biosimilarity to Humira.
A biosimilar is a therapeutic that has similar active properties to an original product — in this case, Humira — but manufactured by a different company. Biosimilars can be approved and manufactured after the original company’s patent expires.
Hulio’s approval by the EC will be applicable across all 28 European Union member countries as well as Norway, Iceland, and Liechtenstein.
Following this decision, Mylan is set to launch Hulio across different countries in Europe either on or after Oct. 16.
“We’re very pleased with the decision of the European Commission to grant marketing authorization for Hulio. This is the fourth product that Mylan will be bringing to market in the area of complex generics and biosimilars, and we’re proud to be a leader in the market formation. We’ve made great progress with Fujifilm Kyowa Kirin Biologics and look forward to continuing this important collaboration,” Rajiv Malik, president of Mylan, said in a press release.
Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier in 2018. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty bearing license with AbbVie, and Mylan has a sublicense for the sale of Hulio in European countries.
“We are delighted that Hulio has received approval from the European Commission,” said Yoshifumi Torii, PhD, Fujifilm Kyowa Kirin Biologics’ president and CEO. “The EC’s approval of Hulio marks a significant milestone. In cooperating with Mylan, we continue to commit all efforts to bring high quality and affordable biosimilars to patients throughout European countries.”
Hulio is indicated for the same adult indications as Humira, including Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, axial spondylarthritis, psoriatic arthritis, psoriasis, hidratenitis suppurativa, and uveitis.
In children, Hulio is indicated for the treatment of Crohn’s disease (6 years and older), polyarticular juvenile idiopathic arthritis (2 and older), and enthesitis-related arthritis (6 and older), plaque psoriasis (4 and older), hidradenitis suppurativa (12 and older), and uveitis (2 and older).
Adalimumab is an injectable therapeutic that inhibits tumor necrosis factor (TNF) — a molecule that promotes inflammation and blocks its activity, reducing inflammation and other symptoms.
“Biosimilars represent a huge opportunity in Europe to drive better patient access through high quality, value medications that support healthcare systems across the region to deliver ongoing excellent care in the face of aging populations and increasingly stretched resources,” said Jacek Glinka, president of Mylan Europe.