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
Type One Energy, Tokamak Energy, and AECOM Form the UK Infinity Fusion Consortium to Accelerate Development of a Commercial Fusion Power Plant in the United Kingdom6.5.2026 10:00:00 CEST | Press release
Type One Energy, Tokamak Energy, and AECOM today announced the UK Infinity Fusion Consortium to pursue development of the first private-sector-led fusion power plant project in the United Kingdom. Together, the companies intend to develop a fusion project that is commercially credible, deployable using existing enabling technologies, and capable of attracting private capital — consistent with the long-term goals of the government’s recently announced UK Fusion Strategy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506129586/en/ (From left to right) Warrick Matthews, CEO of Tokamak Energy; Chris Mowry, CEO of Type One Energy; and Troy Rudd, Chairman and CEO of AECOM sign the UK Infinity Fusion Consortium during His Majesty King Charles III’s visit to New York City. This announcement comes at a time of increasing U.S.-U.K. bilateral cooperation on fusion. His Majesty King Charles III said during his address to the United
59% of Organizations Made a "Bad AI Hire" in the Past Year, New TestGorilla Research Reveals6.5.2026 10:00:00 CEST | Press release
Study of nearly 2,000 senior hiring leaders finds 53% now prioritize AI fluency over domain expertise, but a critical gap between definitions and measurement is producing confident wrong hires on both sides of the Atlantic TestGorilla, the leading skills-based hiring platform, today released The State of Hiring for AI Fluency, revealing a fundamental shift in talent evaluation: AI fluency has overtaken domain expertise as the top hiring priority. 53% of hiring managers now prefer candidates with strong AI fluency over deep subject matter experts. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260506155219/en/ TestGorilla's The State of Hiring for AI Fluency Report Reveals a Transatlantic Divide between US and UK: Study of nearly 2,000 senior hiring leaders finds 53% now prioritize AI fluency over domain expertise, but a critical gap between definitions and measurement is producing confident wrong hires on both sides of the A
Pure Energie Selects Kraken to Manage Wind, Solar and Storage6.5.2026 09:00:00 CEST | Press release
Kraken operating system to manage Pure Energie’s growing portfolio on one intelligent platformPure Energie to benefit from seamless co-ordination across customer load, wind, solar and batteries – maximizing asset value while helping to balance the grid20 sites to onboard in H1 2026, with further expansion planned Pure Energie, a Dutch clean energy company, has selected Kraken – the AI-powered operating system transforming global utilities – to manage and optimize its consumer, wind, solar and battery portfolio across the Netherlands. Kraken brings together grid-scale assets and consumer demand on the same platform, co-ordinating them as a single, intelligent portfolio. This enables Pure Energie to optimize demand and generation in real time – maximizing asset value and helping reduce imbalance costs. The partnership will deliver an energy management system which includes retail balancing, day-ahead curtailment, intraday trading, imbalance optimization, and ancillary market access, alon
Thredd and Currensea Expand Strategic Partnership to Power Next Phase of Growth6.5.2026 09:00:00 CEST | Press release
Four-year renewal builds on long-standing collaboration supporting the payments technology platform behind co-branded reward-earning debit cards and the UK’s top-rated travel spending card Thredd, the AI-first issuer processing platform, today announced the renewal and extension of its longstanding partnership with Currensea, the market-leading payments technology platform. The new agreement extends the relationship for an additional four years, reinforcing a collaboration that has been in place since 2019. Currensea has built a strong reputation among travellers with its multi-bank travel card that links directly to customers’ existing bank accounts, offering competitive FX rates without the need to preload funds. In recent years, Currensea has expanded its offering through co-brand partnerships with leading global travel and hospitality brands, including Hilton Hotels, Marriott Bonvoy and United Airlines, allowing cardholders to earn competitive rewards on their day-to-day debit spen
AMINA Becomes First Bank to Support Canton Coin Trading and Custody6.5.2026 08:30:00 CEST | Press release
Swiss-regulated AMINA provides clients with regulated access to the network that DTCC, Visa, BitGo, and others are building on AMINA Bank AG ("AMINA"), a Swiss Financial Market Supervisory Authority (FINMA)-regulated crypto bank with global reach, today becomes the first bank to support Canton Coin (CC), the native token of Canton Network, offering custody and trading services to its clients. Canton Network is a public, privacy-preserving blockchain built for capital markets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260505860056/en/ AMINA Becomes First Bank to Support Canton Coin Trading and Custody Canton has gained significant institutional momentum in recent months, attracting TradFi and DeFi organizations, including the DTCC, Visa, and BitGo, that are building next-generation settlement, tokenisation, custody, and collateral workflows on the network. Canton is also developing an on-chain capital markets ecosystem t
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