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
(c) 2018 Business Wire, Inc., All rights reserved.
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
Emmaus Life Sciences Announces the New England Journal of Medicine has Published the Phase 3 Trial Results of Endari™ (L-Glutamine Oral Powder) in Sickle Cell Disease18.7.2018 21:45 | Pressemelding
VIEW E-MEDIA KIT – Emmaus Life Sciences, Inc. (Emmaus) announced today that the New England Journal of Medicine (NEJM) has published the results of its 48-week phase 3 clinical trial of Endari™ (L-glutamine oral powder) which supported the FDA approval in July 2017 to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. The article reports results that showed significantly fewer sickle cell crises in those receiving Endari compared to placebo by 25 percent; p=0.005 (median 3 vs. median 4) and significantly fewer hospitalizations by 33 percent; p=0.005 (median 2 vs. median 3). Additional findings showed lower cumulative days in hospital of 41 percent; p=0.02 (median 6.5 days vs. median 11 days) and a lower incidence of acute chest syndrome (ACS) by more than 60 percent; p=0.003 (13 of 152 patients [8.6%] had at least 1 ACS compared with 18 of 78 in the placebo group [23.1%]). The most common adverse reactions, occurring in great
Tigo Releases State-of-the-art Wireless Technology – Mesh – as the New Solar Communication Architecture for the TS4 Platform18.7.2018 19:41 | Pressemelding
Tigo®, pioneer of the smart modular Flex MLPE platform, today announced the release of its new Mesh communication architecture. This state-of-the-art wireless technology directly translates to customer benefits – including simplifying the solar design process and accelerating the commissioning steps. The complete Tigo solution uses a simple yet powerful data collection technology that covers the widest ranges of residential & commercial installations at the lowest cost. With Mesh and the recently announced Tigo Access Point (TAP), customers eliminate the need to address any roof obstruction or orientation constraint. To learn more about Mesh and TAP, register for Tigo’s free, online webinar “The Future of Solar is Wireless” on Wednesday July 25th, 2018 at 10am PDT. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180718005827/en/ Mesh is Tigo's proprietary software that allows each TS4 unit to act as a repeater, extending the
ViiV Healthcare Shares Data from Landmark 2-Drug Regimen Trials At AIDS 201818.7.2018 17:21 | Pressemelding
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, will be presenting over 20 abstracts, including data from the landmark GEMINI 1 & 2 clinical trials, at the 22nd International AIDS Conference (AIDS 2018), 23-27 July 2018, in Amsterdam, The Netherlands. The data being presented this year has a strong focus on novel exploratory therapeutic options and innovative treatment strategies, as well as improving awareness and understanding of key issues that continue to affect the HIV community. John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “As we see advancements in the treatment options available to people living with HIV, our research efforts over the past few years have been focused on moving beyond viral load and addressing some of the unresolved issues that people living with HIV face, such as the potential long-term risks and toxicities that can be associated with li
Xilam: H1 2018 Revenue: +50%18.7.2018 16:00 | Pressemelding
Regulatory News: The Xilam Group (Paris:XIL) posted consolidated H1 2018 revenue of EUR 13,866 thousand, an increase of 50%. This increase represents an excellent performance, as it follows on the heels of growth of 54% in H1 2017. Revenue for the first part of this financial year breaks down as follows. In thousands of euros 30.06.2018 (1) 30.06.2017 Change New productions 8,465 4,571 +85% Catalogue 5,385 4,652 +16% Other 16 16 +0% Revenue and subsidies 13,866 9,239 +50% (1) Unaudited data. Remarkable success for new releases +85% Excellent H1 growth was driven by the two main businesses, New Productions and Catalogue. In New Productions, H1 deliveries generated record revenue of EUR 8,465 thousand, an 85% increase compared with H1 2017, and confirmed Xilam’s position as a major European animation company. Catalogue revenue was up 16% compared with H1 2017, thanks again to traditional TV channels and digital platforms, in both France and abroad. A fast-paced delivery schedule Thanks t
Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 12:38 | Pressemelding
The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign
Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 12:05 | Pressemelding
Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d