Market Overview

IMRALDI®, Biogen's Adalimumab Biosimilar Referencing Humira®, is Approved in the European Union


Biogen becomes the first company with approved biosimilars for the
three most prescribed anti-TNF biologic treatments in Europe.

The European Commission (EC) granted a marketing authorization for
IMRALDI® (also known as SB5), an adalimumab biosimilar
referencing Humira®.1

IMRALDI has been developed by Samsung Bioepis, a joint venture between
Samsung BioLogics and Biogen (NASDAQ, BIIB) and is approved for the
treatment of rheumatoid arthritis (RA), 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 the third anti-TNF biosimilar from Biogen to receive a
marketing authorization in the European Union (EU) following the
approval in 2016 of BENEPALI® (etanercept), a biosimilar
referencing Enbrel®,2 and FLIXABI®
(infliximab), a biosimilar referencing Remicade®.3
Anti-TNF therapies represent some of the EU's largest drug expenditures,
costing an estimated $9 billion (€8 billion) each year from 2011 to 2014.4,5
Introducing biosimilars of the top three anti-TNF therapies in Europe
could lead to estimated potential savings of up to $11.44 billion (€9.69
billion), between the patent expiry date of each reference product and
2020.5,6 With the approval of IMRALDI, Biogen has become the
first company to have approved biosimilars for all three of these

"Today's decision marks another positive step in transforming the lives
of people with chronic autoimmune conditions," said Jean-Paul Kress, EVP
International and Head of Global Therapeutic Operations, Biogen. "As the
number of approved biosimilars continues to grow, so does the
anticipated potential to increase physician choice and patient access to

The EC approval was based on a robust preclinical and clinical data
package comparing IMRALDI with Humira. The clinical data include results
from two head-to-head studies – a Phase I study in healthy volunteers
that demonstrated pharmacokinetic bioequivalence to Humira7
and a 52 week Phase III, randomized, double-blind, multicenter study, in
which IMRALDI demonstrated comparable efficacy and comparable safety and
immunogenicity to Humira in patients with moderate to severe RA despite
methotrexate therapy.8,9 The primary endpoint of the Phase
III study, the American College of Rheumatology 20% (ACR20) response at
Week 24, was met, demonstrating equivalent efficacy to Humira (ACR20
response rate was 72.5% in the IMRALDI group versus 72.0% in the Humira
group).8 Between Week 24 and Week 52, in 125 patients who
were switched from Humira to IMRALDI, efficacy, safety, and
immunogenicity profiles were found to be comparable to those in patients
who remained on Humira (129) or IMRALDI (254) during the transition

About Biogen
Through cutting-edge science and medicine,
Biogen discovers, develops and delivers innovative therapies worldwide
for people living with serious neurological and neurodegenerative
diseases. Founded in 1978, Biogen is a pioneer in biotechnology and
today the Company has the leading portfolio of medicines to treat
multiple sclerosis, has introduced the first and only approved treatment
for spinal muscular atrophy, and is at the forefront of neurology
research for conditions including Alzheimer's disease, Parkinson's
disease and amyotrophic lateral sclerosis. Biogen also manufactures and
commercializes biosimilars of advanced biologics. For more information,
please visit
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Biogen Safe Harbor
This press release includes
forward-looking statements, including statements about the indications
from approval and anticipated access to IMRALDI in the EU, and the
potential cost savings from the availability of IMRALDI and other
biosimilar anti-TNF therapies in the EU. These forward-looking
statements may be accompanied by such words as "anticipate," "believe,"
"estimate," "expect," "forecast," "intend," "may," "plan," "will," and
other words and terms of similar meaning. You should not place undue
reliance on these statements. Drug development and commercialization is
a lengthy and complex process, which involves a high degree of risk.
Factors that could cause actual results to differ materially from our
current expectations include: the risk that unexpected concerns may
arise from additional data or analysis, or 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 our
biosimilar drug candidates; risks related to our dependence on third
parties for the development and commercialization of biosimilars; risks
of legal actions, regulatory scrutiny or other challenges to biosimilars
which could prevent the commercial launch of a product or delay it for
many years; and the risks of other unexpected hurdles. For more detailed
information on the risks and uncertainties associated with our drug
development and commercialization activities, please review the Risk
Factors section of our most recent annual or quarterly report filed with
the Securities and Exchange Commission. These statements are based on
our current beliefs and expectations, and speak only as of the date of
this press release. We do not undertake any obligation to publicly
update any forward-looking statements.


1 Humira® is a registered trademark of AbbVie
Biotechnology Ltd.
2 Enbrel® is a registered
trademark of Wyeth LLC.
3 Remicade® is a
registered trademark of Janssen Biotech, Inc.
Extrapolated from global sales from Global Data PMLive Top 50 report,
available at:
Accessed August 2017
5 Currency exchange rates
(rounded). Available at:
Accessed August 2017.
6 Psachoulia E, et al. Potential
impact of the biosimilars introduction of 3 anti-TNFs in the European
market. Value Health 2017;20(5);A143.
7 Shin D, et al. A
Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar,
And Adalimumab Reference Product (Humira®) in Healthy
Subjects. Ann Rheum Dis 2015;74 (suppl 2):1265.
Weinblatt M, et al. A Phase III, Randomized, Double-Blind Clinical
Study, Comparing SB5, An Adalimumab Biosimilar, with Adalimumab
Reference Product (Humira®) in Patients with Moderate to
Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week
results) [abstract]. Arthritis Rheumatol 2015;67 (suppl 10).
Weinblatt M, et al. FRI0161 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. Annals of the Rheumatic
Diseases 2016;75:487.

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