Mylan (NSDQ:MYL) and Fujifilm Kyowa Kirin Biologics said today that the European Commission gave the companies marketing authorization for Hulio, a biosimilar to AbbVie‘s (NYSE:ABBV) billion-dollar Humira product.
Mylan said it plans to launch Hulio across particular markets in Europe on or after Oct. 16. The drug is the fifth product authorized by the EC as a biosimilar for AbbVie’s Humira. There is no biosimilar for Humira in the U.S.
The EC authorized Hulio for the same indications as Humira, including rheumatoid arthritis and Crohn’s disease.
“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,” Mylan president Rajiv Malik said in prepared remarks.
“We are delighted that Hulio has received approval from the European Commission,” Dr. Yoshifumi Torii, president & CEO of Fujifilm Kyowa Kirin Biologics, added. “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.”
“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,” Jacek Glinka, president of Mylan’s Europe division, said.
AbbVie’s Humira brought in roughly $4.4 billion in sales in Europe for the 12 months ended June 30, 2018, according to IQVIA.