SAMSUNG-BIOEPIS
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
Andersen Consulting samarbejder med TruScore14.11.2025 16:15:00 CET | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med TruScore, som styrker virksomhedens kompetencer inden for humankapital og hjælper kunder med at opbygge stærkere ledelsesteams og organisatoriske kulturer. Truscore, der har hovedsæde i USA, specialiserer sig i at levere fuldt skræddersyede survey-hosting-løsninger, der gør det muligt for organisationer at gennemføre whitelabel-vurderingsordninger, der er skalerbare, sikre og tilpasset deres specifikke behov. TruScore tilbyder avancerede 360-graders feedbackløsninger og samarbejder med Fortune 500-virksomheder, ledelsesudviklingsfirmaer og uafhængige coaches om at designe og administrere deres egne vurderingsplatforme og -oplevelser. "I nutidens dynamiske forretningsmiljø har organisationer brug for mere end blot en strategi – de har brug for stærk og robust ledelse for at kunne omsætte strategien til succes," siger Derek Murphy, CEO for TruScore. "Gennem dette samarbejde med Andersen Consulting kan vi få vores ekspertise inden for
SBC Medical Group Enters the Thai Market through Partnership with BLEZ14.11.2025 13:47:00 CET | Press release
-- Advancing Its Overseas Growth Strategy to Expand Japanese-Quality Aesthetic Medicine Across Asia Following Singapore -- SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a global provider of comprehensive consulting and management services to the medical corporations and their clinics, today announced that it has entered into a Consulting Agreement with BLEZ ASIA Co., Ltd. (Headquarters: Bangkok, Thailand; CEO: Naoki Iida; “BLEZ”), which operates more than 20 pharmacies and clinics in Thailand and is widely trusted by both Japanese expatriates and local patients. The partnership is a key component of SBC’s broader Asia strategy and represents a significant step toward full-scale entry into the rapidly growing Thai aesthetic medicine market. Under the agreement, SBC will provide comprehensive management support to a new clinic focused primarily on dermatological treatments such as pigmentation and spot removal, which BLEZ is preparing to open in
SBC Medical Group Holdings Announces Third Quarter 2025 Financial Results14.11.2025 13:00:00 CET | Press release
SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a global provider of comprehensive consulting and management services to the medical corporations and their clinics, today announced its financial results for the third quarter of fiscal year 2025 (three months ended September 30, 2025) and for the third quarter cumulative of fiscal year 2025 (Year-to-Date 2025, nine months ended September 30, 2025) Third Quarter 2025 Highlights Total revenues were $43 million, representing an 18% year-over-year decrease. Income from operations was $16 million, representing a 15% year-over-year increase. Net Income attributable to SBC Medical Group was $13 million , representing an 353% year-over-year increase. Earnings per share, which is defined as net income attributable to the Company divided by the weighted average number of outstanding shares, was $0.12 for the three months ended September 30, 2025, compared to $0.03 in the same period of 2024. EBITDA1, which
Ant Group Chairman Eric Jing Outlines Strategy for Inclusive AI, Collaboration on Tokenised Settlement14.11.2025 11:15:00 CET | Press release
AI-as-a-Service applications will make AI virtual CFO and COO for SMEsPublic-private collaboration in regulatory sandboxes help to provide clarity and certainty when it comes to new technology like tokenisation and AI Eric Jing, Chairman of Ant Group, said the company's focus is on putting new payment and operation tools powered by AI and tokenisation technology in the hands of SMEs, to fully embrace the next wave of global productivity revolution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251114239737/en/ Ant Group Chairman Eric Jing (second from right) shares insights during a panel discussion titled “Steering the Global Future” during the Singapore FinTech Festival on November 14, 2025. “We are passionate about using frontier technology to support SMEs and the use of AI will really uplift inclusion,” Jing said during a panel discussion titled “Steering the Global Future” during the Singapore FinTech Festival on Novem
Allianz Achieves Record Results and Expects a Full-Year Operating Profit of at Least 17 Billion Euros14.11.2025 07:16:00 CET | Press release
3Q 2025 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251113803211/en/ Oliver Bäte, Chief Executive Officer of Allianz SE Double-digit growth in operating profit and shareholders’ core net incomeTotal business volume rises 5.21 percent with contributions from all segments Operating profit increases 12.6 percent to 4.4 billion euros, with particular strong contribution from the Property-Casualty segment Shareholders’ core net income advances by 12.7 percent and reaches 2.9 billion euros 9M 2025 Continued strong and diversified growth across our businessesand record operating profitTotal business volume rises 8.5 1 percent and reaches 141.2 billion euros with contributions from all segments Operating profit increases 10.4 percent to 13.1 billion euros, our highest nine-month operating profit ever, reaching 82 percent of our full-year outlook midpoint Shareholders’ core net income advances 10.5 percent to 8.4 billion euros. Ad
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