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
Estithmar Holding Reports 97% Surge YoY in Q1 2026 in Net Profit to QAR 333 Mn29.4.2026 20:25:00 CEST | Press release
Strong performance reflects sustained upward momentum driven by international expansion and operational efficiencyDigital transformation initiatives in automation and artificial intelligence enhanced productivity, governance, and cost optimization Estithmar Holding Q.P.S.C. announced its financial results for the first quarter of 2026, reporting a net profit of QAR 333 million, marking a significant 97% increase compared to the same period last year. The results underscore the strength of the Company’s operating model and the successful execution of its expansion strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429718889/en/ Estithmar Holding Reports 97% Surge YoY in Q1 2026 in Net Profit to QAR 333 Mn (Photo: AETOSWire) The company recorded revenues of QAR 1.455 billion, up from QAR 1.309 billion in Q1 2025. Gross profit rose to QAR 561 million compared to QAR 416 million, representing a year-on-year increase of
DC Secretary Announces Annual Determinations Committees Outcome29.4.2026 15:36:00 CEST | Press release
DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 29, 2026. Global Dealer Voting Members (for all Regions): Non-Dealer Voting Members (for all Regions): Bank of America, N.A. Citadel Americas LLC Barclays Bank plc Elliott Investment Management L.P. BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Regional Dealer Voting Member for the Americas, EMEA, Asia Ex-Japan, and Japan Determination Committees: CCP Members for the Americas, EMEA, Asia Ex-Japan, and Australia-New Zealand Determinations Committees: Mizuho Securities Co., Ltd. ICE Clear Credit LLC LCH S.A. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommitte
Driscoll's Names Wyard Stomp Chief Operating Officer and Expands Shaily Sanghvi's Role to Lead Global Strategy29.4.2026 15:00:00 CEST | Press release
Leadership announcements advance Driscoll's global ambition to scale its proven mission of delighting consumers to every market worldwide Driscoll's, the world's leading berry brand, today announced two leadership appointments to support CEO Soren Bjorn's long-term strategy to scale the company's proven, flavor-first business model globally, bringing the same deliberate approach that made Driscoll's the #2 retail food and beverage brand in the United States to consumers in every market the company serves. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429432633/en/ Wyard Stomp has been appointed Chief Operating Officer (COO), a newly created role, while continuing to lead Driscoll's Europe, Middle East, and Africa (EMEA) business. As COO, Stomp will partner closely with the Executive Leadership Team to turn strategy into action, lead cross-functional initiatives, and ensure the company executes at the pace required to sup
Boomi Builds Analyst Momentum Across Integration, API Management, Data Management, and Agentic AI29.4.2026 15:00:00 CEST | Press release
Recent analyst recognitions highlight Boomi’s expanding role in helping enterprises activate trusted data, govern APIs, and operationalize AI at scale Boomi, the data activation company, today announced continued analyst recognition across multiple strategic technology categories, underscoring the company’s momentum as enterprises look for a unified foundation to connect data, applications, APIs, automation, and AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260429987428/en/ Boomi Builds Analyst Momentum Across Integration, API Management, Data Management, and Agentic AI Over the past several months, Boomi has been recognized across integration, API management, data management, and agentic AI-related categories. The company was named a Leader and positioned highest for Ability to Execute in the 2026 Gartner® Magic Quadrant™ for Integration Platform as a Service, marking Boomi’s 12th consecutive year as a Leader. Boomi wa
CSC Urges Enterprises Evaluate Applying for .BRAND Domains to Navigate AI-Driven Domain Threats and Opportunities29.4.2026 15:00:00 CEST | Press release
Upcoming gTLD registration period offers rare opportunity to gain exclusive control over domain infrastructure to mitigate third-party domain risks and AI-driven domain attacks CSC, an enterprise-class domain registrar and world leader in mitigating brand, fraud, domain, and domain name system (DNS) threats, today announced a new program to coincide with ICANN’s new Generic Top-Level Domain (gTLD) application window and to support enterprises submitting a .BRAND TLD application between April 30 and August 12, 2026. Owning a .BRAND domain gives an organization exclusive control over its entire domain infrastructure, mitigating third-party lookalike domain registrations that lead to phishing and domain spoofing. This will be the first time ICANN has opened applications for new gTLDs, including .BRANDs, since the inaugural round in 2012. There is no known date for a third window opening. As the largest provider of these domain services globally, CSC manages more than one-third (160+) of a
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