Samsung Bioepis' RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea
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.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151204005228/en/
Christopher Hansung Ko, President & CEO of Samsung Bioepis (Photo: Business Wire)
“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:
SB4 investigational biosimilar candidate referencing Enbrel
(etanercept): 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®.
SB5 investigational biosimilar candidate referencing Humira
(adalimumab): 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
- SB2, investigational biosimilar candidate referencing Remicade® (infliximab) – European Union, Switzerland, Russia, Turkey
- SB5, investigational biosimilar candidate referencing Humira® (adalimumab) – European Union, Switzerland, Russia, Turkey
- SB4, investigational biosimilar candidate referencing Enbrel® (etanercept) – Worldwide, but excluding United States, European Union, Switzerland, Japan
- SB2, investigational biosimilar candidate referencing Remicade® (infliximab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
- SB5, investigational biosimilar candidate referencing Humira® (adalimumab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
- SB3, investigational biosimilar candidate referencing Herceptin® (trastuzumab) – Worldwide
- SB9 (MK-1293), investigational biosimilar candidate referencing Lantus® (insulin glargine) – Worldwide
Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For more information, please visit: www.samsungbioepis.com.
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00 | Pressemelding
Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are
More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08 | Pressemelding
The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable
Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15 | Pressemelding
Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside
Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03 | Pressemelding
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f
Schlumberger Announces Third-Quarter 2017 Results20.10.2017 11:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the third quarter of 2017. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2017 Jun. 30, 2017 Sept. 30, 2016 Sequential Year-on-year
SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47 | Pressemelding
SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom