Third Biosimilar Adalimumab, Imraldi, Enters Europe

One day after Sandoz and Amgen announced European launches of their biosimilar adalimumab products referencing Humira, Samsung Bioepis announced that it has launched its own biosimilar, Imraldi. According to a company statement, the drug will become available today in major EU markets, though the company did not specify which nations would be first to receive access to the drug.

“The launch of Imraldi marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems,” said Sang-Jin Pak, chief operating officer of Samsung Bioepis. “We hope Imraldi will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market.”

Imraldi’s launch marks Samsung Bioepis’ third EU market entry with an anti—tumor necrosis factor therapy; the company previously launched Benepali, an etanercept biosimilar, and Flixabi, an infliximab biosimilar.

Imraldi was approved in Europe in 2017 on the basis of a randomized, double-blind, 52-week phase 3 study in which 544 patients with moderate to severe rheumatoid arthritis for whom methotrexate was insufficient were randomized to receive either the biosimilar or the reference Humira.

At week 24, response rate for the American College of Rheumatology’s criteria for 20% improvement was 72.4% in the biosimilar arm versus 72.2% in the reference arm. Additionally, the safety profile of Imraldi was comparable to the reference up to week 24. At that timepoint, 254 patients receiving the reference product were randomized 1:1 to either continue to take reference adalimumab or switch to the biosimilar, while the original 254 patients taking Imraldi continued to receive the biosimilar.

The efficacy, safety, and immunogenicity profiles were comparable between all 3 treatment groups till week 52, and there were no treatment emergent issues or clinically-relevant immunogenicity precipitated by the switch.

Imraldi is also under the FDA’s consideration for US approval; in September 2018, Samsung Bioepis announced that the FDA had accepted a Biologics License Application for the drug.

Two approved adalimumab biosimilars are yet to launch in the European Union: Mylan’s Hulio and Boehringer Ingelheim’s Cyltezo. Neither developer has announced a target launch date for its product.