Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016)
Samsung Bioepis Co., Ltd. today announced new clinical data on its anti-TNF-α portfolio of Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate. The data will be presented through seven poster presentations and an abstract publication at the Annual European Congress on Rheumatology (EULAR 2016), which is being held between June 8-11, 2016 in London, United Kingdom. Samsung Bioepis will also operate a booth and host a satellite symposium.
This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160608005570/en/
Christopher Hansung Ko, President & CEO of Samsung Bioepis (Photo: Business Wire)
The poster presentations include switching data for the three Samsung Bioepis anti-TNF-α biosimilar molecules. The 100-, 78- and 52-week Phase III studies for Benepali®, Flixabi® and SB5, respectively, demonstrated comparable efficacy and safety profiles after transitioning from the reference product to the biosimilar version.
“Payers and healthcare providers must be given sufficient clinical evidence, so that they can make informed decisions when deciding whether to switch to a biosimilar treatment option,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Our clinical studies have demonstrated that transitioning from a reference product to its biosimilar version yields comparable outcomes with regards to both the efficacy and safety of treatment.”
Chul Kim, Vice President and Head of the Medical & Lifecycle Safety Team at Samsung Bioepis, added, “Long-term clinical data is essential for anti-TNF-α medicines, as chronic patients suffering from autoimmune diseases require treatment over an extended period of time that can last many years. We hope that our new clinical evidence on switching, as well as long-term efficacy and safety, will assist physicians in their daily decision making process and ultimately help benefit the quality of patient care.”
Highlights of the data are as follows:
also known as SB4
In a randomized, double-blind 100-week Phase III study, 596 patients with moderate to severe rheumatoid arthritis were treated with either weekly dose of subcutaneous 50 mg SB4 or etanercept with background methotrexate. After 52 weeks, 245 patients participated in the extension study. 126 patients continued to receive SB4 (SB4/ SB4) and 119 patients switched from etanercept to SB4 (etanercept/SB4). Among them, 119 (94.4%) patients of SB4/SB4 and 113 (95.0%) patients of etanercept/SB4 completed the 100-week treatment. At Week 100, the efficacy, safety and immunogenicity profiles remained comparable between SB4/SB4 and etanercept/SB4 with ACR20 response rates of 77.9% and 79.1%, respectively. There were no treatment emergent issues, such as loss of efficacy, increase in adverse events or increase in immunogenicity.
also known as SB2
In a randomized, double-blind 78-week Phase III study, 584 patients with moderate to severe rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB2 or infliximab. At Week 54, 396 patients were re-randomized. 94 patients from infliximab were transitioned to SB2 (infliximab/SB2), 101 patients from infliximab continued to receive infliximab (infliximab/infliximab) and 201 patients from SB2 continued to receive SB2 (SB2/SB2). Up to Week 78, the efficacy, safety and immunogenicity profiles remained comparable between the infliximab/SB2, infliximab/infliximab and SB2/SB2. There were no treatment emergent issues or clinically relevant immunogenicity.
SB5 (adalimumab) investigational biosimilar candidate
In a 52-week Phase III study, 508 patients with rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB5 or adalimumab 40 mg every other week via subcutaneous injection. At Week 24, 254 patients from SB5 continued to receive SB5 (SB5/SB5), 125 patients from adalimumab were transitioned to SB5 (adalimumab/SB5) and 129 patients from adalimumab continued to receive adalimumab (adalimumab/adalimumab). At Week 52, the efficacy, safety and immunogenicity profiles remained comparable between SB5/SB5, adalimumab/SB5 and adalimumab/adalimumab with ACR20 response rates of 76.9%, 81.1% and 71.2%, respectively. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching. After transition up to Week 52, the incidence of anti-drug antibody was 15.7% in SB5/SB5, 16.8% in adalimumab/SB5 and 18.3% in adalimumab/adalimumab.
The seven poster presentations and one abstract publication are as follows:
Benepali ® (etanercept), also known as SB4
- LONG-TERM SAFETY AND EFFICACY OF SB4 (ETANERCEPT BIOSIMILAR) IN PATIENTS WITH RHEUMATOID ARTHRITIS: COMPARISON BETWEEN CONTINUING SB4 AND SWITCHING FROM ETANERCEPT REFERENCE PRODUCT TO SB4 [POSTER SESSION: THU0150, June 9, 2016 at 11:45]
Flixabi ® (infliximab), also known as SB2
- COMPARABLE SAFETY AND IMMUNOGENICITY AND SUSTAINED EFFICACY AFTER TRANSITION TO SB2 (AN INFLIXIMAB BIOSIMILAR) VS ONGOING INFLIXIMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS OF PHASE III TRANSITION STUDY [POSTER TOUR: FRI0162, June 10, 2016 at 11:50]
- EFFICACY AND SAFETY ANALYSIS BY OVERALL ANTI-DRUG ANTIBODY RESULTS UP TO WEEK 30 IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH SB2 (AN INFLIXIMAB BIOSIMILAR) OR INFLIXIMAB REFERENCE PRODUCT IN PHASE III STUDY [POSTER SESSION: THU0140, June 9, 2016 at 11:45]
- THE 54-WEEK RESULTS OF INTERFERON-Γ RELEASE ASSAY IN A PHASE III STUDY COMPARING SB2, AN INFLIXIMAB BIOSIMILAR, TO INFLIXIMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS [POSTER SESSION: THU0149, June 9, 2016 at 11:45]
SB5 (adalimumab) investigational biosimilar candidate
- SUSTAINED EFFICACY AND COMPARABLE SAFETY AND IMMUNOGENICITY AFTER TRANSITION TO SB5 (AN ADALIMUMAB BIOSIMILAR) VS CONTINUATION OF THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULT OF PHASE III STUDY [POSTER TOUR: FRI0161, June 10, 2016 at 11:50]
- SECONDARY EFFICACY RESULTS UP TO WEEK 24 FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMIAR) WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY [POSTER SESSION: THU0138, June 9, 2016 at 11:45]
- IMPACT OF ANTI-DRUG ANTIBODIES ON EFFICACY AND SAFETY UP TO WEEK 24 FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMILAR) WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY [POSTER SESSION: THU0146, June 9, 2016 at 11:45]
- A PHASE I PHARMACOKINETIC STUDY COMPARING PRE-FILLED PEN AND PRE-FILLED SYRINGE OF SB5, AN ADALIMUMAB BIOSIMILAR IN HEALTHY SUBJECTS [ABSTRACT PUBLICATION]
Samsung Bioepis will operate a booth at the Annual European Congress on Rheumatology (EULAR 2016), where visitors can learn about the company. The booth will be located in Stand 200, Hall S16, South Event Halls (Level 1) of ExCeL London.
Samsung Bioepis will also host a satellite symposium, titled, Biosimilars: Your questions answered, which will address key questions regarding biosimilars and their impact on the management of rheumatoid arthritis. The symposium will take place between 8:15-9:45 on June 10, 2016 in Room 7, ICC Capital Suite of ExCeL London. Topics include:
- What do you think about biosimilars?
- How does Samsung Bioepis rapidly develop and manufacture high quality biosimilars?
- How are biosimilars regulated and monitored?
- How can clinicians interpret biosimilar studies?
- What if biologics were readily available?
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 13 biosimilar candidates that include six first-wave product 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.
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00 | Pressemelding
Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are
More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08 | Pressemelding
The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable
Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15 | Pressemelding
Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside
Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03 | Pressemelding
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f
Schlumberger Announces Third-Quarter 2017 Results20.10.2017 11:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the third quarter of 2017. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2017 Jun. 30, 2017 Sept. 30, 2016 Sequential Year-on-year
SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47 | Pressemelding
SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom