INCHEON, Republic of Korea, September 7, 2015 – Samsung Bioepis – the South Korean-based biopharmaceutical company, announced today that MFDS, the South Korean regulatory authority, has approved BRENZYS® – a biosimilar version of etanercept, previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and psoriasis. The MFDS approval of BRENZYS was based on data from a Phase I study in 138 healthy male subjects and a Phase III randomized clinical study in 596 patients with rheumatoid arthritis (RA) . In the Phase III study, RA patients were randomized to receive either 50mg of BRENZYS® or 50mg of Enbrel® subcutaneously once weekly for up to 52 weeks. The primary endpoint was the American College of Rheumatology 20 percent response criterion (ACR20) at week 24, and the results showed an equivalent efficacy and safety profile for BRENZYS® to originator etanercept.
The results of the Phase I and Phase III studies were presented at the Annual Congress of the European League Against Rheumatism (EULAR) held in Rome, Italy, on 10–13 June 2015. Subsequently, the Phase III study results were published in EULAR’s official medical journal, Annals of the Rheumatic Diseases
"The approval of BRENZYS® demonstrates Samsung Bioepis’ ability to develop biosimilars in accordance with stringent regulatory pathways and with shorter development timelines than others,” said Christopher Hansung Ko, Ph.D., CEO of Samsung Bioepis.
"BRENZYS® represents an affordable solution for patients and hence provides an opportunity for expanded patient access to this quality of life enhancing and life-saving medication. With this first approval, and an extensive biosimilars development pipeline, we look forward to continuing to provide value-creating solutions for patients globally."
In South Korea, BRENZYS® will be commercialized in partnership with MSD Korea. MSD Korea plans to launch BRENZYS® by the end of this year or early next year
Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, was established in 2012 as part of the Samsung group. The company’s mission is to produce affordable, high-quality biopharmaceutical products for diseases with high unmet medical, humanistic and economic needs. The company aims to be the world’s leading biopharmaceutical company with its efforts for innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.
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