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
Seoul Semiconductor’s SunLike Series LEDs Win Product of the Year Award from Elektronik Magazine23.3.2018 18:28 | Pressemelding
Seoul Semiconductor, a global innovator of LED products and technology, announced on March 23rd that its SunLike Series natural spectrum LED product won the Gold Award at the Elektronik Product of the Year 2018 Awards, hosted by Elektronik (http://www.elektroniknet.de), a leading German electronics publication. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005646/en/ Product of the Year Award from Elektronik Magazine (SunLike) (Photo: Business Wire) As a publication specializing in electrical and electronic components, “Elektronik” is a prestigious magazine with an illustrious history and the largest number of subscribers in Germany. Over the past 20 years, they have conducted annual surveys among their subscribers to find the “most creative and innovative products.” Based on these survey results, Elektronik selects the top product that with the most impact in its corresponding field, and confers the awards accordingl
Elliott Welcomes Imminent Bezeq Board Overhaul and New Era for Strong Independent Governance23.3.2018 16:05 | Pressemelding
Elliott Advisors (UK) Limited (“Elliott”), which advises funds which collectively hold a significant economic interest in Bezeq The Israeli Telecommunication Corporation Ltd. (“Bezeq” or the “Company”), welcomes the proposed governance reforms announced by Bezeq last night. In its initial letter to Bezeq Interim Chairman David Granot, dated January 16, 2018, Elliott outlined the urgent need to address the Company’s serious corporate governance issues, and called for changes at the Board level that result in “the right mixture of expertise, independence and integrity for the future.” Elliott stated then, and reiterates now, its belief that “there is significant value to be unlocked if the right steps are taken to improve its corporate governance.” Bezeq has strong business fundamentals, an exemplary workforce, and great potential. Following yesterday’s announcement, Elliott highlights the changes that have occurred since January 16th. Taken together, these amount to a revolution in the
Clovis Oncology Initiates Early Access Program for Rucaparib as Treatment and as Maintenance Therapy in Recurrent Ovarian Cancer in Europe23.3.2018 12:52 | Pressemelding
Clovis Oncology, Inc. (NASDAQ:CLVS) today announced the initiation of an early access program in Europe for rucaparib for treatment and as maintenance therapy in recurrent ovarian cancer. The program will be overseen and implemented by Caligor Coghlan, which specializes in early access to medicines. The program, to be known as the Rucaparib Access Program (RAP), will enable participation from certain countries in Europe, where permitted by applicable rules, procedures and regulatory authorities. The RAP protocol allows for rucaparib treatment of an individual patient with third-line or greater BRCA mutant epithelial, fallopian tube, or primary peritoneal ovarian cancer who has platinum-sensitive disease and is unable to tolerate further platinum-based chemotherapy or has platinum-resistant disease and needs treatment with single agent rucaparib. The RAP protocol will also provide access to rucaparib for maintenance therapy of an individual patient with recurrent epithelial ovarian, fal
CHMP Grants Positive Opinion for Clovis Oncology’s Rubraca® (rucaparib) Tablets23.3.2018 12:50 | Pressemelding
Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that the European Union’s (EU) European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for Rubraca as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapy. The European Marketing Authorization application for the treatment indication was based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2, in women with advanced BRCA mutant ovarian cancer who had progressed after two or more prior chemotherapies. “The recommendation
Janssen Announces Positive CHMP Opinion for JULUCATM▼ (dolutegravir/rilpivirine)23.3.2018 12:46 | Pressemelding
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a Positive Opinion recommending marketing authorisation for JULUCA™ (dolutegravir 50mg [ViiV Healthcare UK Ltd]/rilpivirine 25mg [Janssen Sciences Ireland UC]). Dolutegravir/rilpivirine is a single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase strand transfer inhibitor (INSTI).1 “We are delighted to be one step closer to bringing JULUCA™ to people living with HIV in Europe,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, LLC. “Building on our 25-year c
Aitheon Executives Educate World Leaders on Benefits, Challenges of AI at the Annual World Government Summit in Dubai23.3.2018 12:00 | Pressemelding
Aitheon, makers of the world’s first blockchain-powered platform to solve real problems by integrating AI, robotics, IoT, human specialists and cryptocurrency, announced today that executives from the company held a series of high-level briefings with world leaders at the Annual World Government Summit in Dubai. Briefings covered the benefits and challenges of AI, and revolutionary new solutions to world challenges made possible by transformative new technologies. (Read the full release at www.aitheon.com/news) This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180323005269/en/ Aitheon founder and CEO, Andrew Archer, and Chief Strategy Officer, Ryan Burleson, were invited to brief leaders at the Summit by Cyrus Hodes, Co-founder and Director of the AI Initiative, an undertaking of the Future Society at Harvard University’s Kennedy School. Archer and Burleson addressed a variety of AI-related topics, including the impact of AI on