IMRALDI®, Biogen’s Adalimumab Biosimilar Referencing Humira®, is Approved in the European Union
August 24 2017 - 7:05PM
Business Wire
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 therapies.
“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 biologics.”
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 period.9
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
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.
References
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.4 Extrapolated from
global sales from Global Data PMLive Top 50 report, available at:
http://www.pmlive.com/top_pharma_list/Top_50_pharmaceutical_products_by_global_sales.
Accessed August 20175 Currency exchange rates (rounded). Available
at: www.xe.com. 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):1265.8 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).9 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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BIOGEN EU MEDIA CONTACT:Ryan Furby, +41 413 920
652publicaffairs.EU@biogen.comorBIOGEN INVESTOR CONTACT:Mike
Hencke, +1 781-464-2442IR@biogen.com
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