-- Primary Efficacy Analysis Demonstrates Clinical Equivalence
First Phase 3 Data from Samsung Bioepis' Study --
INCHEON, Republic of Korea –Samsung Bioepis Co., Ltd. today announced that its pivotal Phase 3 clinical study of SB5, an investigational biosimilar of Humira (adalimumab), met its primary endpoint, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) 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 adalimumab.
SB5 is being developed as a biosimilar to adalimumab, an anti-TNF-α 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.
About Rheumatoid Arthritis Rheumatoid Arthritis (RA) is a chronic disorder that primarily affects the joints, resulting typically in warm, swollen, and painful joints. Pain and stiffness are often worsened following rest. Most commonly affected areas are the wrists and the hands, although the disease may also affect other parts of the body. This may result in low red blood cells, inflammation around the lungs, and inflammation around the heart. Fever and low energy may also be present. Often, symptoms worsen gradually over weeks to months. RA affects between 0.5 and 1% of adults in the developed world with between 5 and 50 per 100,000 people newly developing the condition each year.
About Samsung Bioepis
Samsung Bioepis was incorporated in 2012 as part of the Samsung group, through a joint venture partnership between Samsung Biologics and Biogen. The company's mission is to produce affordable, high-quality biopharmaceutical products to patients in need. The company aims to be the world's leading pharmaceutical company with its effort for innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.
CONTACT: Samsung Bioepis, INCHEON, Republic of Korea
Jamyung Cha, 82-32-455-6137 (Media) Sungjoon Park, 82-32-455-6120 (Investors)
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