Samsung Bioepis and AbbVie Settle Humira Biosimilar Patent Dispute

Imraldi, a biosimilar referencing Humira, is expected to launch initially in Europe.

Samsung Bioepis and AbbVie have settled patent disputes over the commercialization of Samsung Bioepis’ SB5, a biosimilar referencing adalimumab (Humira), according to a press release. The 2 companies signed a licensing agreement to settle all pending patent litigation, clearing the way for the product’s commercialization in all approved markets worldwide.

SB5 is indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn disease, pediatric Crohn disease, ulcerative colitis, and uveitis.

The European Commission granted marketing authorization to SB5 to be commercialized in Europe as Imraldi by Biogen. It has not yet received regulatory approval in the United States.

In a 52-week phase 3 study, 544 patients with moderate-to-severe RA despite methotrexate therapy were randomized to receive either Imraldi or the adalimumab reference product (ADL). At week 24, the ACR20 response rate was 72.4% in the Imraldi group versus 72.2% in the ADL group. Additionally, at this time, 254 patients receiving ADL were re-randomized to continue ADL or switch to Imraldi and 254 patients receiving SB5 continued to receive it. Up to week 52, the efficacy, safety, and immunogenicity profiles remained comparable between all 3 treatment groups.

“We welcome this agreement which clears the way for SB5 in approved markets across the world,” Jaywood Kim, Senior vice president and head of the commercial division at Samsung Bioepis, said in the press release. “The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region.”

In December 2017, Samsun Bioepis’ SB3 trastuzumab biosimilar candidate was accepted for review by the FDA. If approved, SB3 will be commercialized in the United States by Merck.

According to the press release, Imraldi is expected to launch in Europe on October 16, 2018.


Samsung Bioepis Settles Patent Disputes with AbbVie, Clearing the Way for the Commercialization of SB5 (Adalimumab) in All Approved Markets Worldwide [news release]. Accessed April 5, 2018.

Samsung Bioepis First to Obtain European Commission Approval for a Third Anti-TNF-α Biosimilar with Imraldi™(adalimumab) [news release]. Samsung Bioepis’ website. Accessed April 5, 2018.