Biogen’s IMRALDI®, an Adalimumab Biosimilar Candidate Referencing Humira®, Granted Positive Opinion by Committee for Medi...
June 23 2017 - 7:55AM
Business Wire
If approved, IMRALDI would be the third
anti-TNF biosimilar in Biogen’s portfolio in Europe, helping to
expand affordable therapy options and increase access for patients
with chronic anti-inflammatory disorders such as rheumatoid
arthritis
Humira is the number-one prescribed biologic
therapy in the world and accounts for almost half of anti-TNF
healthcare expenditures in Europe
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 BiogenThrough 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
www.biogen.com. Follow us on social media – Twitter, LinkedIn,
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Biogen Safe HarborThis 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.
References
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).6
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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BIOGEN EU MEDIA CONTACT:Benjamin Russell, +41 41 392
1922publicaffairs.EU@biogen.comorBIOGEN INVESTOR CONTACT:Mike
Hencke, +1 781-464-2442IR@biogen.com
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