Samsung Bioepis' RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea
4.12.2015 09:14 | Business Wire
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
Samsung Bioepis and Takeda Sign Strategic Collaboration Agreement to Co-Develop Multiple Novel Biologic Therapies20.8.2017 23:30 | Pressemelding
Samsung Bioepis Co., Ltd. announced today that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited (TSE: 4502) to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas. The two companies will immediately begin working on the program’s first therapeutic candidate, TAK-671, which is intended to treat severe acute pancreatitis. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170820005028/en/ Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire) “Takeda’s extensive knowledge and expertise in drug development makes the company an ideal partner for us as we open a new chapter at Samsung Bioepis,” said Christopher Hansung Ko, President and CEO, Samsung Bioepis. “Five years ago, we entered
The Valence Group Issues Fairness Opinion to SK Capital in Connection with Archroma18.8.2017 13:30 | Pressemelding
The Valence Group has provided a fairness opinion to SK Capital Partners, LP in connection with its recapitalization of Archroma, including investments made by various affiliates of SK Capital. Terms of the transaction were not disclosed. About SK Capital SK Capital is a private investment firm focused on the specialty materials, chemicals and pharmaceutical sectors. The firm builds strong and growing businesses that generate substantial long-term value for its investors. SK Capital utilizes its industry, operating and investment experience to identify opportunities to transform businesses into higher performing companies with improved strategic positioning, growth, profitability and risk profiles. The firm currently has approximately $1.9 billion of assets under management and its portfolio companies generate revenues of over $5.0 billion annually and employ approximat
Biker Summer 2017 campaign: What’s happening during Biker Summer 2017? Moto-tyres.co.uk is giving away exciting prizes!18.8.2017 09:22 | Pressemelding
Whether it’s a short weekend break or a long-distance tour – once again this year Moto-tyres.co.uk is asking bikers from 10 countries about their dream destinations and longest journeys as part of its “Biker Summer 2017” campaign. To ensure than nothing gets in the way of your next tour, the two-wheeler tyre store from Delticom, Europe’s leading online tyre dealer, is entering anyone who completes the survey before 30 September 2017 into a prize draw to win some great biking accessories. Simply answer three short questions about your plans for bike tours this year (don’t forget to provide your name and email address), and with a bit of luck, you might win one of these great prizes. Up for grabs are a GARMIN motorbike GPS system, a GoPro camera with helmet bracket and five 200-Pound vouchers for new motorbike tyres from the online store – thanks to the product range at Moto-tyres.co.uk, eve
Lenovo Continues to Gain Momentum in First Quarter FY 2017/1818.8.2017 00:04 | Pressemelding
Behind the strength of its 3-wave strategy, Lenovo’s business transformation continued to gain traction during the first quarter, delivering solid profitability in its core PC and smart devices business, and revenue and profit improvements in targeted growth areas, including the data center and mobile businesses. Fueled by new investments in people and products, Lenovo’s Data Center Group (DCG) introduced the most comprehensive product lineup in its history, with the new ThinkSystem and ThinkAgile portfolio, and continued to build out its end-to-end sales organization. Similarly, Lenovo’s Mobile Business Group launched significant new products led by the Moto Z2 Force, available now on all major U.S. carriers, and ramped up its branding efforts worldwide. “In the first quarter this fiscal year, we had stable performance as we executed our 3-wave strategy with commitment. We
Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 15:57 | Pressemelding
Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio
Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 12:08 | Pressemelding
On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom