Market Overview

Biogen's IMRALDI®, an Adalimumab Biosimilar Candidate Referencing Humira®, Granted Positive Opinion by Committee for Medicinal Products for Human Use


The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has issued a positive opinion for IMRALDI®
(also known as SB5), an adalimumab biosimilar candidate
referencing Humira®.1 The positive opinion will
now be referred to the European Commission (EC), which grants marketing
authorization for medicines in the European Union (EU). IMRALDI marks
the third anti-TNF candidate to be submitted to the EMA by Samsung
Bioepis, the joint venture between Samsung BioLogics and Biogen.

If approved by the EC, IMRALDI would be approved for the treatment of
rheumatoid arthritis, axial spondyloarthritis, ankylosing spondylitis,
plaque psoriasis, psoriatic arthritis, Crohn's disease, ulcerative
colitis, polyarticular juvenile idiopathic arthritis, active
enthesitis-related arthritis, hidradenitis suppurativa and
non-infectious uveitis.

Today, the anti-TNF market alone accounts for an estimated $9 billion of
healthcare expenditures in Europe,2 of which Humira accounts
for $4 billion.2 Global sales estimates for Humira stand at
$16 billion in 2017, making it the number-one prescribed biologic
therapy in the world.3 Earlier this year, data were unveiled
at the ISPOR 22nd Annual Meeting in Boston showing that
biosimilar introduction of the top-three anti-TNF therapies in Europe
could result in savings of $11.44 billion by 2020.4 Of these
savings, $3.18 billion could be attributed to prescribing an adalimumab
biosimilar referencing Humira, despite only being approved near the end
of the study period.4

"If IMRALDI receives approval, Biogen will be the first company to have
approved biosimilars of the three most prescribed anti-TNF biologic
treatments in Europe," said Alpna Seth, Ph.D., Senior Vice President and
Global Head of the Biosimilars Business Unit at Biogen. "This portfolio
expansion is in line with our mission to increase access to biologics
that have transformed the treatment of chronic autoimmune conditions
like rheumatoid arthritis. Being able to provide this range of anti-TNF
treatment alternatives bolsters our leadership position and underscores
our commitment to expanding physician choice, while supporting the
sustainability of healthcare systems."

The positive opinion is 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 Humira5
and a Phase III, randomized, double-blind, multicenter study, in which
IMRALDI demonstrated equivalent efficacy and comparable safety and
immunogenicity to Humira in patients with RA.6 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.6 Secondary endpoints demonstrated that
IMRALDI has a comparable safety and immunogenicity profile to Humira.6

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 potential
indications for IMRALDI, and the potential approval of IMRALDI 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; 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 Extrapolated from global sales from
Global Data PMLive Top 50 Report.
3 Gibney M.
FiercePharma special report: The top 20 drugs in 2020 – worldwide sales
(1. Humira).
4 Psachoulia et al. Potential impact of the
biosimilars introduction of 3 anti-TNFs in the European market. Value
Health 2017, May; 20(5); A143.
5 Shin D, Kim Y, Kim HS,
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 ME, Baranauskaite A, Niebrzydowski J, 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).

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