Samsung Bioepis’ Biologics License Application for infliximab biosimilar accepted by FDA

May 24, 2016 11:14 AM

Samsung Bioepis Co., Ltd. announced that the U.S. FDA has accepted for review the company’s Biologics License Application for SB2, a biosimilar candidate referencing Remicade, for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the US. If approved, the marketing and distribution of SB2 in the US will be handled by Merck, in accordance with a commercialization agreement signed in 2013.

“At Samsung Bioepis, we are dedicated to bringing affordable, high-quality biologic medicines to patients across the United States. Already in other countries, our biosimilars have started to play an important role in increasing patient access to high-quality treatment options, while driving down healthcare expenditures. We hope to do the same in the US,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We will continue our relentless drive for innovation and further advance one of the industry’s largest biosimilar pipelines, so that more patients can have access to affordable medicines without compromising the quality of treatment.”

Samsung Bioepis’ BLA for SB2 was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of SB2 to Remicade. In a 54-week Phase 3 clinical study, SB2 showed comparable safety and equivalent efficacy to Remicade, as evidenced in ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.

Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates, which includes the following six first-wave product candidates that cover the therapeutic areas of immunology, oncology and diabetes:

SB4 biosimilar candidate referencing Enbrel® (etanercept)
SB2 biosimilar candidate referencing Remicade® (infliximab)
SB5 biosimilar candidate referencing Humira® (adalimumab)
SB9 (MK-1293) biosimilar candidate referencing Lantus® (insulin glargine)
SB3 biosimilar candidate referencing Herceptin® (trastuzumab)
SB8 biosimilar candidate referencing Avastin® (bevacizumab)

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