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
Align Partners Issues Third Public Shareholder Letter and Submits Formal Shareholder Proposals to Coway14.2.2026 12:31:00 CET | Press release
Align Partners highlights Coway’s persistent undervaluation despite steady global growth, citing structural ROE decline as a key driver Align Partners urges the Board to address inefficient capital structure and strengthen shareholder return discipline; requests a formal response by March 13, 2026 The proposals call for stronger Board independence, enhanced Audit Committee oversight, and improved compensation transparency Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Coway Co., Ltd. (“Coway” or the “Company”), has submitted formal shareholder proposals for the Company’s upcoming 37th Annual General Meeting (“AGM”) and issued its third public shareholder letter to Coway’s Board of Directors. Coway is South Korea’s leading home appliance rental platform, supported by a strong global brand and sales network. Since Netmarble became the largest shareholder in 2020, Coway has delivered steady operating growth, with revenue and operating profit increasing at comp
HM King Mohammed VI Presides Over the Launch Ceremony of the Aircraft Landing Gear Production Plant Project, Representing an Investment of €280 million by the Safran Group in Morocco13.2.2026 21:10:00 CET | Press release
His Majesty King Mohammed VI, may God assist Him, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur, a project that reinforces Morocco as a destination of choice and a true integrated industrial actor at the heart of the global economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213269786/en/ His Majesty King Mohammed VI, accompanied by HRH Crown Prince Moulay El Hassan, chaired on Friday at the Royal Palace in Casablanca the presentation and launch ceremony of the project to build a landing gear production factory for Safran in Nouaceur Considered one of the largest manufacturing centres in the world for Safran Landing Systems, the plant will represent an investment of more than EUR 280 million, create 500 jobs, and operate on 100% decarbonised energ
Sultan bin Ahmed visits Huawei R&D Centre and SMG in China13.2.2026 18:52:00 CET | Press release
His Highness Sheikh Sultan bin Ahmed bin Sultan Al Qasimi, Deputy Ruler of Sharjah and Chairman of the Sharjah Media Council, visited the Huawei Research and Development Centre and Shanghai Media Group (SMG) in Shanghai, People’s Republic of China. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213682693/en/ Sultan bin Ahmed visits Huawei R&D Centre and SMG in China (Photo: AETOSWire) His Highness toured Huawei Village, which spans 2.2 million square metres and comprises over 100 buildings and laboratories, employing more than 30,000 staff. He observed the master plan of the village and its key facilities that support the company’s business strategy and product development. He also reviewed the specifications of the buildings, constructed to the highest standards, and the diverse services provided to employees, including restaurants, cafes, entertainment venues, and rest areas. The center also offers easy access via train
Andersen Global tilføjer samarbejdsfirmaet Pi Advisory13.2.2026 17:23:00 CET | Pressemeddelelse
Andersen Global styrker sine kompetencer i Afrika gennem en samarbejdsaftale med Pi Advisory, et finansielt rådgivningsfirma baseret i Angola og med afdelinger i Mozambique og Portugal. Pi Advisory tilbyder en bred række af ydelser, herunder fuld skatteservice, forretningssupport og outsourcing, finansiel rådgivning samt en bred vifte af selskabsrelaterede ydelser, der hjælper kunder med alt fra etablering af nye virksomhedsenheder til at navigere i lokale skatteregler. Firmaet integrerer principper for miljø-, samfunds- og ledelsesmæssige forhold (ESG) i sin drift, hvilket afspejler dets engagement i en bæredygtig forretningspraksis. "Dette samarbejde styrker vores evne til at støtte kunder med komplekse behov på tværs af jurisdiktioner," udtalte António Amaral Correia, partner hos Pi Advisory. "Gennem vores samarbejde med Andersen Global kan vi levere løsninger, der imødekommer de skiftende krav fra kunder på de portugisisktalende markeder såvel som globalt." Mark L. Vorsatz, global
Volue Welcomes TA Associates as New Strategic Investor13.2.2026 11:15:00 CET | Press release
Partnership Strengthens Volue’s Position as a European Leader in Electrification Technology Volue, a global leader in electrification and energy technology, today announced that TA Associates (“TA”), a leading global private equity firm, has joined as a new strategic investor alongside Advent International (“Advent”), Generation Investment Management (“Generation”) and Arendals Fossekompani. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260213436945/en/ Over the past 18 months, Volue has undergone a strategic transformation to sharpen its focus on the energy sector. During this period, Volue divested non-core activities and invested in targeted R&D innovation and strategic acquisitions to further position Volue as a leading provider of integrated technology solutions for power trading and generation, grid optimization, and energy market intelligence. Operating at the center of one of the most mission-critical markets of our
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