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
(c) 2018 Business Wire, Inc., All rights reserved.
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
Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 15:58 | Pressemelding
A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The
Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 15:27 | Pressemelding
Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio
H.I.G. Capital Announces the Sale of Kondor13.7.2018 14:06 | Pressemelding
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced today that one of its affiliates has sold Kondor Limited, a specialist provider of category management solutions for audio and mobile accessory products into the retail and mobile network channels in the UK and Europe, to DCC Technology (which principally trades under the Exertis brand), part of DCC plc, the leading international sales, marketing and support services group. Terms of the transaction were not disclosed. Headquartered in Dorset, England, Kondor distributes audio and mobile accessory products to a broad range of e-tail, retail and mobile operator customers. H.I.G. invested in Kondor in 2014, and has since overseen a full reorganisation of the business. H.I.G. worked in partnership with Kondor to professionalise back office systems, develop Kondor’s access to market data, optimise the company’s product range, improve stock manag
Contactless Technology Powers Fifty Percent of Purchases at 2018 FIFA World Cup Russia™13.7.2018 09:00 | Pressemelding
Visa (NYSE: V), the Official Payment Services Partner of FIFA, today released an analysis of spending inside the 2018 FIFA World Cup Russia™ stadiums from the opening match on June 14 through the semi-finals on July 11. The data highlights the increased consumer adoption of innovative payment technology, as fifty percent of purchases with Visa in tournament venues utilized contactless transactions, including cards, mobile devices and wearables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180713005025/en/ For the 2018 FIFA World Cup Russia™, Visa is the exclusive payment service in all stadiums where payment cards are accepted. In-stadium, fans can pay with contactless Visa credit and debit cards and mobile payment services at the more than 3,500 point-of-sale terminals and 1,000 mobile concessionaires that have been equipped with the latest in payment innovation. (Photo: Business Wire) Visa cardholders on average spent 1,
Brazil Approves AerSafe for Airbus 321 Aircraft to Comply with Fuel Tank Flammability Reduction Rule12.7.2018 19:18 | Pressemelding
AerSale ® announced today that the National Civil Aviation Agency of Brazil (ANAC) has approved the Federal Aviation Administration’s (FAA’s) Supplemental Type Certificate (STC) for the company’s AerSafe™ system on Airbus 321 aircraft (ST04010NY), that complies with the Fuel Tank Flammability Reduction (FTFR) rule. This is the second ANAC STC approval for AerSafe, following approval on Boeing 737 CL aircraft in 2017. In the coming months, AerSafe will be expanded to cover additional aircraft types, to meet the September 2019 deadline of the ANAC regulation, Regulamento Brasileiro da Avaiação Civil (RBAC) nº 121.1117, that applies specifically to passenger aircraft that fly within or into Brazil. AerSale’s STCs for the Boeing 737 CL and NG series (ST02980NY) and Boeing 767 series (ST03599NY) have already been approved by the FAA. “We are pleased that our Latin American customers operating A320 family aircraft are now able to immediately benefit from AerSafe’s numerous advantages,” said
Blockchain-based Adents NovaTrack Issues Token to Standardize Access to Comprehensive Supply Chain Traceability12.7.2018 18:20 | Pressemelding
Adents, leading serialization and track & trace solutions provider, announces the issue of tokens that, combined with its NovaTrack platform, will standardize access to full supply chain traceability. Adents recently released Adents NovaTrack, a marriage of technologies co-developed with Microsoft. The solution utilizes Blockchain, A.I., IoT and serialization functionalities that, when combined, bring comprehensive visibility throughout product distribution chains & life cycles. The result is a solution highly mindful not only in terms of performance and security, but also governance and scalability. With NovaTrack, Adents aims to create an ecosystem of consortium-based blockchains independent from each other, and individually launched on-demand by various supply chain stakeholders (brands, manufacturers, logistics professionals, etc.). Each consortium-based blockchain will provide a secure environment to its participants to share supply chain data and processes. From brands, manufactu