SAMSUNG-BIOEPIS
27.9.2018 01:02:06 CEST | Business Wire | Press release
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB5, a biosimilar candidate referencing HUMIRA® i (adalimumab). The BLA for SB5 was submitted by Samsung Bioepis in July 2018.
The BLA for SB5 was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either SB5 or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group versus 72.2% in the ADL group. The safety profile of SB5 was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.
Outside of the United States, SB5 has so far received regulatory approval from the European Commission, Korea's Ministry of Food and Drug Safety, Australia's Therapeutic Goods Administration and Health Canada.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180926006096/en/
Contact:
MEDIA CONTACT: Samsung Bioepis Co., Ltd. Mingi Hyun +82-31-8061-1594 mingi.hyun@samsung.com
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sceye og SoftBank Corp. indgår aftale om en flåde af stratosfæriske platforme, der skal sikre dækning i hele Japan9.11.2026 02:38:00 CET | Pressemeddelelse
Den femårige aftale bygger videre på Sceyes vellykkede test af stratosfærisk forbindelse i Japan og tager et skridt nærmere fuld udrulning af HAPS som stratosfærisk infrastruktur og som en hjørnesten i SoftBanks strategi om et allestedsnærværende netværk Sceye, en amerikansk virksomhed inden for rumfart og materialeteknologi, der udvikler højtflyvende platformssystemer (HAPS) til infrastruktur i stratosfæren, annoncerede i dag en femårig rammeaftale (MSA) med SoftBank Corp. (TOKYO:9434, "SoftBank") om at fremstille, opsende og drive en flåde af Sceyes HAPS-platforme over Japan med det mål at opnå dækning i hele landet. Aftalen videreudvikler virksomhedernes partnerskab fra demonstrationsflyvninger til fuldt udbygget infrastruktur i stratosfæren. Der er multimedier i denne pressemeddelelse. Se hele meddelelsen her: https://www.businesswire.com/news/home/20261103165280/da/ Sceye and SoftBank Corp. Sign Agreement for Fleet of Stratospheric Platforms Targeting Nationwide Coverage in Japan
COP31: World Cannot Afford Another Decade of Fossil Fuel Dependence as Climate Crisis Deepens8.11.2026 06:05:00 CET | Press release
350.org calls on governments gathering at UN climate talks in Türkiye to turn promises into action, make polluters pay and deliver a just transition away from fossil fuels As world leaders prepare to gather in Antalya for COP31, 350.org is warning that the world cannot afford another decade of delay in transitioning away from fossil fuels. The UN climate conference starts amidst the largest fossil fuel crisis in history and people all over the world are facing increasingly devastating climate impacts while fossil fuel companies continue to rank obscene profits. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261107414423/en/ Ahead of COP31, 350 Türkiye raised a “Climate Justice, Now” banner at Antalya’s Kaleiçi Harbor, urging world leaders to commit to a just transition away from fossil fuels. Photo credit: Caner Özkan / 350.org 350.org is calling on the Turkish and Australian COP31 presidencies to build on this momentum and
IntouchCX Recognized for Operations led AI and End to End CX Transformation by HFS Research6.11.2026 15:00:00 CET | Press release
IntouchCX a global leader in AI-powered customer experience (CX) management, trust and safety, digital engagement, and back-office operations, has been positioned in the Horizon 2 end-to-end experience transformation, in the HFS Horizons Customer Experience Services 2026 report for its operations led approach to AI adoption and its model connecting advisory with delivery, from strategy through frontline executions. HFS Research evaluates customer experience service providers based on their capabilities, innovation, and potential to deliver value. The 2026 report examines how providers are helping businesses adopt AI, improve customer experiences and strengthen operations. “AI transformation delivers the greatest value when strategy, technology, and operations work together,” said Brent Stevenson, Chief Experience Officer at IntouchCX. “Our approach and expertise goes beyond technology. We identify business challenges and build the right solutions by connecting the dots between data, wo
The Estée Lauder Companies Unveils Mastering Skin Longevity, a Breakthrough Scientific Innovation Platform Advancing the Next Era of Skin Science6.11.2026 15:00:00 CET | Press release
New Platform Focuses on Master Regulators of Skin Longevity to Drive Discovery Across Ingredients, Technologies, Formulations and Future Product Innovation At the China International Import Expo (CIIE), The Estée Lauder Companies Inc. (NYSE: EL) today unveiled Mastering Skin Longevity, a breakthrough scientific innovation platform designed to advance the next era of skin science and transformative product innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261106776704/en/ The Estée Lauder Companies' Skin Longevity Clock serves as the visual representation for the Mastering Skin Longevity scientific innovation platform. Moving beyond the study of individual Hallmarks of Aging, the platform focuses further upstream on the Master Regulators of Skin Longevity. These interconnected biological pathways and proteins influence multiple hallmarks at once. By deepening understanding of these systems and how they help support s
Experian Named a Leader in 2026 IDC MarketScape for Worldwide Decision Intelligence Platforms6.11.2026 15:00:00 CET | Press release
IDC MarketScape recognizes Experian for strengths in proprietary data foundation, integrated orchestration and deployment flexibilityKey SummaryExperian named a Leader: IDC MarketScape positions Experian as a Leader in its 2026 vendor assessment of worldwide decision intelligence platform providers. Data and decisioning at scale: Experian Ascend Platform™ brings together proprietary data, analytics, decisioning, fraud detection, identity verification and model management and is used to process millions of transactions daily. Agentic AI orchestration and governance: Experian Agent Operating System™ provides a trusted agentic AI layer within Experian Ascend Platform designed to help organizations scale AI with explainability, auditability and human oversight. Experian today announced it has been named a Leader in the IDC MarketScape: Worldwide Decision Intelligence Platforms 2026 Vendor Assessment (Doc #US54118426, September 2026), which evaluates providers helping organizations design,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom