Samsung Bioepis’ marketing authorization application for SB5 adalimumab biosimilar accepted for review by EMA

July 18, 2016 8:49 AM

Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for SB5, a biosimilar candidate referencing Humira (adalimumab).

SB5 is Samsung Bioepis’ third anti-TNF-alfa biosimilar candidate submitted for review to the EMA, following Benepali (etanercept) and Flixabi (infliximab), both of which have since received European Commission approval in January 2016 and May 2016, respectively. If approved, the marketing and distribution of SB5 in Europe will be handled by Biogen.

“If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down healthcare spending,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We will continue to work hard to advance one of the industry’s largest biosimilar pipelines, so that more patients can access affordable medicines without any compromise in the quality of treatment.”

The MAA for SB5 was based on data derived from a 52-week Phase III study which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. 24-week results showed ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the adalimumab arm, while the safety profile of SB5 was comparable to adalimumab. At Week 24, 508 patients with rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB5 or adalimumab 40 mg every other week via subcutaneous injection. 254 patients from SB5 continued to receive SB5 (SB5/SB5), 125 patients from adalimumab were transitioned to SB5 (adalimumab/SB5) and 129 patients from adalimumab continued to receive adalimumab (adalimumab/adalimumab).

At Week 52, the efficacy, safety and immunogenicity profiles remained comparable between SB5/SB5, adalimumab/SB5 and adalimumab/adalimumab with ACR20 response rates of 76.9%, 81.1% and 71.2%, respectively. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching. After transition up to Week 52, the incidence of anti-drug antibody was 15.7% in SB5/SB5, 16.8% in adalimumab/SB5 and 18.3% in adalimumab/adalimumab.

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