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
Power Integrations Extends Flyback Topology to Enable 440 W, Offering Simpler Alternatives to Resonant Power Designs23.3.2026 22:45:00 CET | Press release
New TOPSwitchGaN ICs more than double power output, reducing system cost, complexity, and design time APEC 2026 – Power Integrations (NASDAQ: POWI), the leader in high-voltage integrated circuits for energy-efficient power conversion, today introduced a breakthrough in flyback topology extending the power range of flyback converters to 440 W—well beyond the limits that traditionally required more complex resonant and LLC topologies. The new TOPSwitchGaN™ flyback IC family unites the company’s groundbreaking PowiGaN™ technology with its iconic TOPSwitch™ IC architecture, reducing complexity, eliminating heat sinks in many cases, shortening design time, improving manufacturability, and lowering total system cost. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323686299/en/ The new TOPSwitchGaN™ flyback IC family extends the power range of flyback converters to 440 W—well beyond the limits that traditionally required more co
I-Pulse Announces Strategic Partnership to Advance Geothermal Pulsed Power Applications in the Millungera Basin, Australia23.3.2026 22:40:00 CET | Press release
I-Pulse to assume operational control of Millungera Basin Geothermal Project with Sunrise Energy Metals, Greenvale Mining Millungera Basin Total Identified Stored Energy Estimated to Exceed 611,000 Petajoules, or 600x Australia’s Current Annual Electricity Consumption I-Pulse’s G-Pulse Tool Deploys High Pulsed Power to Unlock Access to Geothermal Energy I-Pulse Co-Founder, Chairman, and CEO Robert Friedland, I-Pulse Co-Founder and Head of Technology Laurent Frescaline, and Sunrise Energy Metals Managing Director Sam Riggall, are delighted to announce a partnership to deploy and validate I-Pulse’s G-Pulse pulsed power drilling technology in the Millungera Basin, a large-scale geothermal clean energy resource located in northwest Queensland, Australia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323421297/en/ Left: Millungera Basin location in Queensland, Australia. Right: Millungera Basin (in brown) to the east of the M
The Estée Lauder Companies’ Statement on Potential Transaction with Puig23.3.2026 21:15:00 CET | Press release
The Estée Lauder Companies Inc. (NYSE: EL) confirms that it is in discussions regarding a potential business combination with Puig, in which the two companies would potentially merge their businesses. No final decision has been made, and no agreement has been reached. Unless and until an agreement is signed between the companies, there can be no assurances regarding the deal or its terms. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding a potential transaction and the anticipated timing, terms, and completion of any such transaction. Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the possibility that no agreement will be reached, tha
Kinaxis Recognized as a Leader in the 2026 Gartner® Magic Quadrant™ Reports for Supply Chain Planning23.3.2026 19:12:00 CET | Press release
Recognition based on company’s Completeness of Vision and Ability to Execute Kinaxis® Inc. (TSX: KXS), a global leader in supply chain orchestration, today announced it has been positioned as a Leader in both the 2026 Gartner® Magic Quadrant™ for Supply Chain Planning Solutions for Discrete Industries and the 2026 Gartner® Magic Quadrant™ for Supply Chain Planning Solutions for Process Industries. In both reports, Gartner recognized Kinaxis for its ability to execute and completeness of vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260323129357/en/ Kinaxis Recognized as a Leader in the 2026 Gartner® Magic Quadrant™ Reports for Supply Chain Planning: Discrete Industries Kinaxis has been recognized as a Leader in the Gartner® Magic Quadrant™ for Supply Chain Planning Solutions for eleven times in a row. Kinaxis has also been recognized as a Leader in the 2026 Gartner Magic Quadrant for Supply Chain Planning Solutions
Armis Centrix™ Named “Best Solution” for Cyber Exposure Management as Armis Wins Multiple Global InfoSec Awards at RSAC 202623.3.2026 17:00:00 CET | Press release
Armis awarded “Publisher’s Choice Cybersecurity Company”Yevgeny Dibrov received “Industry Pioneering CEO” Armis, the cyber exposure management & security company, today announced that it has won multiple Global InfoSec Awards from Cyber Defense Magazine at this year’s RSAC™ Conference. Armis received the following accolades: Armis Centrix™ won “Best Solution” for Cyber Exposure Management Armis named “Publisher’s Choice Cybersecurity Company” Yevgeny Dibrov, Armis’ CEO and Co-Founder, awarded “Industry Pioneering CEO” “We cannot safeguard modern infrastructure with yesterday’s tactics; the extended attack surface demands a unified, AI-driven approach that sees, protects and manages all assets (IT, OT, IoT, IoMT, applications, code, cloud and AI) in real time,” said Yevgeny Dibrov, CEO and Co-Founder of Armis. “Armis secures the most complex environments of organizations and governments worldwide to protect society from the destruction cybercriminals seek to cause. These awards reinforc
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