World News: 00:05 GMT Wednesday 12th June 2019. [Biogen Inc. via Globe Newswire via SPi World News]
CAMBRIDGE, Mass., June 11, 2019 (GLOBE NEWSWIRE) -- (Nasdaq: BIIB) today announced that it will present new data at the European Congress of Rheumatology (EULAR) 2019 in Madrid, Spain (June 12-15). The abstracts include real-world data from the company’s biosimilar anti-TNF portfolio, which includes BENEPALI (etanercept), FLIXABI (infliximab) and IMRALDI (adalimumab). Biosimilars are products that are demonstrated to be similar to or interchangeable with approved biological product and have the potential to lower drug costs. In Europe, approximately 145,000 patients have been treated with a Biogen biosimilar and the company expects the uptake of these products to generate 1.8 billion euros in healthcare cost savings in 2019.
“These new real-world data reinforce Biogen’s ongoing commitment to providing innovative and value-based therapeutic options to tens of thousands of patients with unmet medical need,” said Ian Henshaw, vice president and head of Biogen’s global biosimilars unit. “The cost savings we generate through our biosimilars business unit will help alleviate global healthcare system burden, which could enable governments to allow broader access to critical therapies.”
To compile real-world evidence, physicians ask patients open-ended questions about treatment experience. The real-world data to be presented at EULAR this year provide further insight into patient experience with anti-TNF biosimilars, including adherence data.
“Patients with chronic inflammatory diseases face the reality of a lifetime of ongoing disease management and now biosimilars enable more patients access to those life-changing medicines while providing our healthcare systems significant savings,” said Dr. Peter Taylor, Norman Collisson professor of musculoskeletal sciences, Nuffield department of orthopedics, rheumatology and musculoskeletal sciences at the University of Oxford, England. “The new real-world data to be presented at EULAR further establish the comparable safety and efficacy of biosimilars against their reference products.”
Biosimilars represent an important component of Biogen’s European portfolio. Biosimilar products benefit patients and are strategically important as Biogen works with payers and health systems globally with the goal of creating room in healthcare budgets to provide access for patients to innovative therapies.
Biogen and its collaboration partner Samsung Bioepis will present a total of nine abstracts at the congress. In February 2012 Biogen entered into a joint venture agreement with Samsung BioLogics, establishing an entity, Samsung Bioepis, to develop, manufacture and market biosimilar products.
Data to be presented include results of the real-world data generating BENEFIT study, which evaluated the outcomes of transition from the reference product etanercept to its biosimilar in routine clinical practice. The study demonstrated no clinically significant difference in disease score from baseline to six months post transition in 533 patients suffering from rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA).
Additionally, data from a pooled analysis of etanercept, infliximab and adalimumab biosimilars and reference products across 1,461 patients will be presented. The analysis demonstrated similar outcomes between biosimilars and their respective reference products in terms of disease fluctuation at six months and one year of treatment .
Further abstracts evaluating the efficacy, safety and retention rates of anti-TNF biosimilars in rheumatology include:
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These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation the occurrence of adverse safety events and/or unexpected concerns that may arise from additional information or further studies; risks of unexpected costs or delays; regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of Biogen’s biosimilar drug candidates; risks related to Biogen’s dependence on third parties for the development and commercialization of biosimilars; unexpected concerns may arise from additional data, analysis or results obtained during clinical trials; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; the risks of other unexpected hurdles; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as result of new information, future developments or otherwise.
BIOGEN GLOBAL MEDIA CONTACT:David CAOUETTE+1 617 679 4945
BIOGEN EU MEDIA CONTACT: Marc BURI+41 79 944 9064 BIOGEN INVESTOR CONTACT:Mike HENCKE+1 781 464 2442
Globe Newswire: 00:05 GMT Wednesday 12th June 2019
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