Samsung Bioepis’ Humira biosimilar meets primary endpoints in phase 3 rheumatoid arthritis trial

July 14, 2015 6:40 AM

Samsung Bioepis Co., Ltd. last week announced that its pivotal Phase 3 clinical study of SB5, an investigational biosimilar of Humira, met its primary endpoint, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy.

The primary endpoint was the American College of Rheumatology 20 percent response criteria (ACR20), at week 24. At week 24, the ACR20 improvement from baseline was within the prespecified equivalence margin for SB5 compared to Humira (adalimumab).

SB5 is being developed as a biosimilar to adalimumab, an anti-TNF-? monoclonal antibody, which was approved in many countries for the treatment of autoimmune diseases, including rheumatoid arthritis, plaque psoriasis (PsO), psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. The active ingredient of SB5 has the same amino acid sequence as adalimumab, and SB5 has the same pharmaceutical dosage form and strength as adalimumab (U.S.) and adalimumab (EU).

“We have developed SB5 folllowing SB4 and SB2. Now we have developed biosimilars for three of the best-selling biologics for autoimmune disease.” said Christopher Hansung Ko,Ph.D., chief executive officer at Samsung Bioepis. “We look forward to providing increased access to patients suffering from autoimmune diseases within the same healthcare budget, and consequently bend the curve of rising healthcare costs worldwide”.

Samsung Bioepis has been developing six biosimilar molecules and expects to launch those products starting in 2016. Marketing Authorization Application for SB2 and SB4 have been submitted to health authorities in the EU and South Korea. Additional biosimilars in development by the South Korean company, are SB9 –an insulin glargine biosimilar candidate, which is currently in phase 3 clinical studies, SB3 –an investigational biosimilar of Herceptin, also in phase 3, and SB8 – an investigational biosimilar of Avastin, which is currently in phase 1 clinical studies.

Source: Samsung Bioepis

1 Comment

  • It would be interesting to see how Samsung fares in the Biosimilars race. With the current results and pipeline, the outcome definitely looks promising.

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