Samsung Bioepis’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea
INCHEON, Korea – December 4, 2015 – Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This marks the second regulatory approval for Samsung Bioepis in Korea. The MFDS approved in September 2015 Samsung Bioepis’ BRENZYS®, a biosimilar version of Enbrel® (etanercept), also known as SB4.
“We look forward to the introduction of RENFLEXIS® in Korea, where patients suffering from autoimmune diseases will soon have access to an affordable, high-quality biologic treatment option,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “With an extensive pipeline of biosimilars on the way, we will continue to leverage our strengths in product development and quality assurance to bring these life-enhancing medications to patients who need them most.”
Samsung Bioepis is solely responsible for the development of all immunology and oncology biosimilars in its pipeline, including RENFLEXIS®, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilars. As according to the commercialization agreement signed in 2013 with Merck, MSD Korea will be responsible for the marketing, sales and distribution of RENFLEXIS® in Korea.
In a 54-week Phase 3 clinical study, RENFLEXIS® showed comparable safety and equivalent efficacy to Remicade®, as evidenced in ACR20 response rate of 65.3% in the RENFLEXIS® arm versus 69.2% in the Remicade® arm. The RENFLEXIS® study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.
In addition to RENFLEXIS®, Samsung Bioepis has been developing two other anti-tumor necrosis factor-alpha (anti-TNF-α) investigational biosimilar candidates, the latest developments for which are as follows:
On November 9, 2015 at the Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) in San Francisco, Samsung Bioepis announced 52-week Phase 3 SB4 clinical study results that showed comparable safety and equivalent efficacy to Enbrel®, as evidenced in ACR20 response rate of 80.8% in the SB4 arm versus 81.5% in the Enbrel® arm. The SB4 study randomized 596 patients across 70 sites in 10 countries. In September 2015, Korea’s MFDS approved SB4, which will be commercialized by MSD Korea as BRENZYS®. In November 2015, the European Medicines Agency (EMA) announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on SB4, marking the first time the CHMP has adopted a positive opinion on an etanercept biosimilar. If a marketing authorization is granted by the European Commission (EC), SB4 will be commercialized in the European Union (EU) as Benepali®.
On November 10, 2015 at the ACR/ARHP Annual Meeting in San Francisco, Samsung Bioepis announced 24-week Phase 3 clinical study results that showed comparable safety and equivalent efficacy to Humira®, as evidenced in ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira® arm. The study randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 52 sites in seven countries.
About Samsung Bioepis Co., Ltd.
Samsung Bioepis was established in 2012 with a mission to develop affordable, high-quality biopharmaceutical products and to provide better patient access to these life-enhancing medications. The company aims to be the world’s leading biopharmaceutical company through innovations in product development and quality assurance.
Samsung Bioepis has commercial agreements with Biogen and Merck to commercialize and distribute biosimilar products in immunology, oncology and diabetes. The products and geographic responsibilities include:
· SB4, investigational biosimilar candidate referencing Enbrel® (etanercept) – European Union, Switzerland, Japan