Samsung Bioepis Settles Patent Disputes with AbbVie, Clearing the Way for the Commercialization of SB5 (Adalimumab) in All Approved Markets Worldwide
Samsung Bioepis Co., Ltd. today announced that it has signed a licensing agreement with AbbVie Inc., settling all pending patent litigation between the two companies and clearing the way for the worldwide commercialization of Samsung Bioepis’ SB5, a biosimilar referencing Humira® i (adalimumab), in all approved markets worldwide. Under the terms of the agreement, SB5 may be launched in Europe from October 16, 2018 onwards and, if approved, in the United States (US) from June 30, 2023 onwards.
SB5 has been granted marketing authorization by the European Commission (EC) as IMRALDI®, and will be commercialized in Europe by Biogen. In the US, SB5 has not yet received regulatory approval.
“We welcome this agreement which clears the way for SB5 in approved markets across the world. The earliest impact of this agreement will likely be seen in Europe, where SB5 has already been approved and is expected to become our third TNF inhibitor available in the region,” said Jaywoo Kim, Senior Vice President and Head of the Commercial Division at Samsung Bioepis. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients and healthcare systems across the world may benefit from biosimilars.”
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that includes six late-stage candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.
i Humira ® is a registered trademark of AbbVie Inc.
Samsung Bioepis Co., Ltd.
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
ABB Showcases World-Leading e-Vehicle Fast Chargers and Launches AI Readiness Index at Hannover22.4.2018 10:00 | Pressemelding
ABB spotlighted its world-leading Terra HP family of fast chargers for electric vehicles at Hannover Messe, the biggest global industrial trade fair. By operating at powers of up to 350 kilowatts and adding as much as 300 kilometers of range to an electric vehicle in just 12 minutes, the Terra HP family of chargers have made electric cars more appealing for consumers by enabling them to refresh the batteries in about the same time required for filling up a petrol-powered car. Terra HP chargers are being installed around the world, and they have been selected for use by Electrify America, the biggest electric vehicle infrastructure project to date in the United States. ABB, whose broad array of digitally driven technologies for electric-power management are used by utilities and businesses worldwide, is also a global leader in industrial automation and robots enabled by artificial intelligence (AI). Demonstrating its commitment to helping the international community address the opportun
PSE: APM Forum 2018 Focus on Digitalisation for the Process Industries20.4.2018 15:13 | Pressemelding
At the 2018 Advanced Process Modelling (APM) Forum this week, process industry organisations presented on digital design and operations applications ranging from accelerating development of the next generation of pharmaceuticals to realising millions of dollars per year in increased profit for large process plants. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005517/en/ Ben Weinstein, head of R&D Product and Process Systems Modeling at Procter & Gamble, delivers the keynote speech on how digital design techniques are used systematically to accelerate innovation in P&G. (Photo: Business Wire) Introducing the conference, Prof. Costas Pantelides, MD of conference host Process Systems Enterprise (PSE), described the current wave of digitalisation as the culmination of many years of advanced modelling and IT development. “This is a time of extraordinary opportunities for the process industries” he said. Keynote speaker Ma
Aperta Provides Electronic Funds Transfer (EFT) in Cayman Islands20.4.2018 14:01 | Pressemelding
Once again, the Aperta Active Clearing System (ACS) has delivered the mechanism for a country to implement a world-class electronic payment processing environment to maximize a national payments system’s efficiency, effectiveness, security and control. Aperta partnered with the Cayman Islands ACH Operator (Prism Services (Cayman) Ltd.) and local commercial banks to deliver a new Electronic Funds Transfer system. The old process of banks swapping files in a wide-variety of standards and settling bilaterally has been replaced with a common system and standards, employing international-standard secure file transfer protocol, allowing participants to monitor real time net settlement and collateral positions via a secure portal. The Cayman Islands Automated Clearinghouse (CIACH) links all six of the country’s banks and provides the central clearing and settlement mechanism for banks to exchange direct debit and direct credit transactions seamlessly across the country. It is functionally NAC
FII Tech Growth Invests in SECO20.4.2018 13:39 | Pressemelding
FII Tech Growth, a fund managed by Fondo Italiano d’Investimento SGR, announces today its second investment in SECO SpA, one of the European leaders in the embedded electronics market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180420005413/en/ (Photo: SECO) SECO, headquartered in Arezzo, Tuscany, with subsidiaries in the U.S.A., Germany and Taiwan, was founded in 1979 by entrepreneurs Daniele Conti and Luciano Secciani. The company designs and manufactures micro-computers and integrated systems for industrial applications. With more than 250 employees, SECO supports customers with a worldwide presence such as Cimbali, Esaote, Technogym and Vimar, and generated revenue in excess of Euro 50 million in 2017. The ability to offer innovative solutions by using cutting-edge technologies has allowed SECO to grow steadily over time. The company developed a network of collaborations with universities and research centres La Sapi
Schlumberger Announces First-Quarter 2018 Results20.4.2018 11:05 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the first quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Mar. 31, 2018 Dec. 31, 2017 Mar. 31, 2017 Sequential Year-on-year Revenue $7,829 $8,179 $6,894 -4% 14% Pretax operating income $974 $1,155 $757 -16% 29% Pretax operating margin 12.4% 14.1% 11.0% -169 bps 145 bps Net income (loss) - GAAP basis $525 $(2,255) $279 n/m 88% Net income, excluding charges & credits* $525 $668 $347 -21% 51% Diluted EPS (loss per share) - GAAP basis $0.38 $(1.63) $0.20 n/m 90% Diluted EPS, excluding charges & credits* $0.38 $0.48 $0.25 -21% 52% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “As forecast, our results in the first quarter of 2018 largely reflected transitory factors, with seasonal reductions in activity in the Northern Hemisphere and planned project startup costs
Biogen and Ionis Expand Strategic Collaboration to Develop Drug Candidates for a Broad Range of Neurological Diseases20.4.2018 10:30 | Pressemelding
Biogen (Nasdaq: BIIB) and Ionis Pharmaceuticals (Nasdaq: IONS) announced today they have expanded their strategic collaboration through a new ten-year collaboration agreement to develop novel antisense drug candidates for a broad range of neurological diseases. This collaboration capitalizes on Biogen’s expertise in neuroscience research and drug development and Ionis’ leadership in RNA targeted therapies with the goal of developing a broad pipeline of investigational therapies. It builds upon a productive collaboration that produced SPINRAZA, the first and only approved treatment for patients with spinal muscular atrophy. Today, April 20, 2018, Biogen and Ionis will host company conference calls and webcasts to discuss the new collaboration. Full webcast details can be found below. Under the terms of the collaboration, Biogen will pay Ionis $1 billion in cash, which will include $625 million to purchase 11,501,153 shares of Ionis common stock at a price of $54.34 per share, at an appr