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Biogen to present new safety and efficacy data on biosimilars and estimates 1.8 Billion Euros in savings for the European Healthcare System in 2019

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Thursday, June 13, 2019

CAMBRIDGE, Mass. - Biogen Inc. (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)(June 14, 11:45.-13:30 CET – FRI0103 – Hall 10).

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 treatment3(June 15, 10:30-12:00 CET – SAT0162 – Hall 10).

About BENEPALI (etanercept)
BENEPALI™ (etanercept), a biosimilar referencing Enbrel®5, was approved by the European Commission (EC) in January 2016 for the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. BENEPALI is currently available in 25 countries in Europe and is the most prescribed etanercept in the five largest European countries (Germany, UK, France, Italy and Spain).6

About FLIXABI (infliximab)
FLIXABI (infliximab), a biosimilar referencing Remicade®7, was approved by the European Commission (EC) in May 2016 for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis. FLIXABI can also be used in patients 6-17 years old with severe, active Crohn’s disease or severely active ulcerative colitis when they have not responded to or cannot take other medicines or treatments. FLIXABI is currently available in 17 countries in Europe.8

About IMRALDI (adalimumab)
IMRALDI (adalimumab), a biosimilar referencing Humira®9, was approved by the European Commission (EC) in August 2017 for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis and uveitis. IMRALDI is currently available in 18 countries in Europe and is the leading adalimumab biosimilar in Germany and in Europe.10,11

About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first approved treatment for spinal muscular atrophy and is focused on advancing neuroscience research programs in MS and neuroimmunology, Alzheimer’s disease and dementia, movement disorders, neuromuscular disorders, acute neurology, neurocognitive disorders, pain and ophthalmology. Biogen also commercializes biosimilars of advanced biologics.

We routinely post information that may be important to investors on our website at www.biogen.com.

Contact:

BIOGEN GLOBAL MEDIA CONTACT:
David CAOUETTE
+1 617 679 4945
public.affairs@biogen.com

BIOGEN EU MEDIA CONTACT: 
Marc BURI
+41 79 944 9064
marc.buri@biogen.com

BIOGEN INVESTOR CONTACT:
Mike HENCKE
+1 781 464 2442
IR@biogen.com

Source: biogen
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