Biogen & Samsung Bioepis Agree to Settlement with AbbVie Allowing Commercialization of IMRALDI™ (Adalimumab Biosimilar) in ...
05 April 2018 - 10:05PM
Business Wire
Biogen expects to launch IMRALDI in Europe on
October 16, 2018
Biogen will be the first company to offer
biosimilars of all three major anti-TNF therapies in Europe
Biogen Inc. (Nasdaq: BIIB) and its partner Samsung Bioepis
announced today an agreement with AbbVie (NYSE: ABBV) for the
commercialization of IMRALDI, a biosimilar referencing HUMIRA®
(adalimumab). Under terms of the agreement, AbbVie will grant
patent licenses for the use and sale of IMRALDI in Europe, on a
country-by-country basis, and Biogen and Samsung Bioepis will make
royalty payments to AbbVie. The companies have agreed to dismiss
all pending patent litigation.
Biogen expects to launch IMRALDI in Europe on October 16, 2018,
which will complement its existing portfolio of anti-TNF therapies,
BENEPALI™ (etanercept) and FLIXABI™ (infliximab).
“Biogen is a leader in the emerging field of biosimilars through
Samsung Bioepis, our joint venture with Samsung BioLogics,” said
Ian Henshaw, Global Head of Biosimilars at Biogen. “Biogen already
markets two biosimilars in Europe and the planned introduction of
IMRALDI on October 16 could potentially expand patient choice by
offering physicians more options to meet the needs of patients
while delivering significant savings to healthcare systems.”
The precise terms of the agreement with AbbVie are
confidential.
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. Founded in 1978 as one of the
world’s first global biotechnology companies by Charles Weissmann,
Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter
Gilbert and Phillip Sharp, today Biogen has the leading portfolio
of medicines to treat multiple sclerosis; has introduced the first
and only approved treatment for spinal muscular atrophy; and is
focused on advancing neuroscience research programs in Alzheimer’s
disease and dementia, multiple sclerosis and neuroimmunology,
movement disorders, neuromuscular disorders, pain, ophthalmology,
neuropsychiatry, and acute neurology. Biogen also manufactures and
commercializes biosimilars of advanced biologics. We routinely post
information that may be important to investors on our website at
www.biogen.com.
To learn more, please visit www.biogen.com and follow us on
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Safe Harbor
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements relating to the
potential benefits, safety, and efficacy of IMRALDI, planning and
timing for commercial launch, and the potential of Biogen’s
commercial business and pipeline programs, including IMRALDI,
BENEPALI, and FLIXABI. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” and other words and terms of
similar meaning. Drug development and commercialization involve a
high degree of risk, and only a small number of research and
development programs result in commercialization of a product. You
should not place undue reliance on these statements or the
scientific data presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including uncertainty of success in
commercialization of IMRALDI, which may be impacted by, among other
things, the level of preparedness of healthcare providers to treat
patients, difficulties in obtaining or changes in the availability
of reimbursement for IMRALDI, the effectiveness of sales and
marketing efforts, problems with the manufacturing process for
IMRALDI, the occurrence of adverse safety events, failure to obtain
regulatory approvals in other jurisdictions, failure to protect
intellectual property and other proprietary rights, 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 Securities and Exchange
Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this press
release. Biogen does not undertake any obligation to publicly
update any forward-looking statements, whether as a result of new
information, future developments, or otherwise.
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Biogen Inc.MEDIA CONTACT:David Caouette, +1
617-679-4945public.affairs@biogen.comorINVESTOR CONTACT:Matt
Calistri, +1 781-464-2442IR@biogen.com
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