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
Footprint Expands Into PE-Free Cups, Bringing a Proven, Recyclable and Home-Compostable Alternative to Plastic-Lined Paper Cups Into Production21.7.2026 18:00:00 CEST | Press release
Move strengthens Footprint’s European manufacturing platform and supports growing demand for practical alternatives to single-use plastic Footprint, a materials science and technology company focused on eliminating single-use plastics, today announced it has acquired a recyclable, home-compostable, polyethylene (PE)-free hot and cold cup platform from Transcend Packaging, along with next-generation paper lid and straw solutions. Transcend Packaging is a European company focused on innovation in sustainable packaging solutions. Together, the cup, lid, and straw expand Footprint’s portfolio with a proven solution for the global cup market. Footprint will begin scaling its new PE-free solution through its Poland facility as the company expands across Europe, with North America to follow. As operations ramp in Poland, Footprint will work with Transcend through a manufacturing partnership to support customer continuity across Europe and meet growing demand for practical alternatives to plas
Spectro Cloud Launches PaletteAI Inference Launchpad to Reduce Enterprise Token Costs by up to 70%21.7.2026 16:00:00 CEST | Press release
New turnkey, locally managed PaletteAI Inference Launchpad helps enterprises control token costs with local-first inference, while expanded PaletteAI support for AMD gives customers more choice across GPUs, models and AI infrastructure stacks. Spectro Cloud, a leading provider of AI infrastructure management software, today launched PaletteAI Inference Launchpad, a turnkey, locally managed solution designed to help enterprises reduce token costs by as much as 70% and run AI inference closer to their data, applications and users. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721597271/en/ The company also announced expanded PaletteAI support for AMD-powered AI infrastructure, including AMD GPUs, AMD GPU Operator, ROCm™ runtime, and the AMD enterprise AI reference stack — including AMD-optimized models from the AMD Inference Microservices (AIMs) catalog. Together, the announcements expand PaletteAI as one platform for prod
RecVue Launches First AI Native Agentic Revenue Operating System21.7.2026 15:03:00 CEST | Press release
New agentic architecture for RevOS runs enterprise revenue across the order-to-cash lifecycle and surfaces cross-system intelligence RecVue, the leader in billing and revenue management solutions, today announced the evolution of RecVue RevOS into the industry's first Agentic Revenue Operating System. In an architectural shift, the now-native agentic revenue management platform moves revenue operations beyond AI-assisted workflows to fully governed, autonomous execution with more than 50 purpose-built agents that work across contracts, invoices and payment data to predict risk, surface anomalies and escalate exceptions throughout the quote-to-cash lifecycle. Enterprise revenue operations have long suffered from a structural gap between billing systems that generate invoices and ERP systems that record transactions. Finance teams face tedious, manual reconciliation month after month, often resulting in delayed cash, billing errors that generate disputes, revenue leakage from ungoverned
Yubico Extends Passkeys Beyond Trusted Authentication to Verified Authorization with Launch of YubiKey 5.821.7.2026 15:00:00 CEST | Press release
YubiKey 5.8 extends hardware-backed assurance from authentication into emerging digital signature, wallet, payment and agentic approval workflows Yubico (NASDAQ STOCKHOLM: YUBICO), the pioneer of phishing-resistant authentication and creator of the original passkey, the YubiKey, today announced the general availability of its YubiKey 5.8 – marking an expansion of the role of the passkey from secure authentication to include verifiable, hardware-backed authorization. The new firmware delivers a foundation for secure enterprise workflows across identity wallets, document signing, and AI-driven approvals, while also providing developers with the critical capabilities needed to test, design and deploy these next-generation security features early. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260721286409/en/ As generative and agentic AI mature to drive rapid, automated cyberattacks, traditional multi-factor authentication (MFA
Gurobi Publishes Inaugural State of Mathematical Optimization in Academia Report21.7.2026 15:00:00 CEST | Press release
Findings showcase how academics are leveraging optimization alongside GenAI tools in the classroom and in research today. Gurobi Optimization, LLC, the leader in decision intelligence technology, today announced the publication of its inaugural State of Mathematical Optimization in Academia Report. Based on surveys of over 1,180 faculty and students who actively use Gurobi, the report examines how optimization is being taught, used in research, and applied across academia today—as well as use cases that could benefit from a combination of generative AI (GenAI) with optimization. Gurobi’s research highlights the importance of making optimization education and tools accessible to students and instructors. “Mathematical optimization is powering some of the most effective decision-making across today’s enterprises, and the academic community is key to advancing its theory and practice,” said Duke Perrucci, CEO, Gurobi. “By exploring how students, researchers, and educators are teaching and
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