IMRALDI™, Biogen’s Adalimumab Biosimilar Referencing Humira®, Is
Launched in the European Union
Samsung Bioepis Co. Ltd, a joint venture between Samsung BioLogics
and Biogen (Nasdaq: BIIB) today announced the European launch of
IMRALDITM, an adalimumab biosimilar referencing Humira®.1
IMRALDI is approved in Europe for the treatment of rheumatoid
arthritis (RA), juvenile idiopathic arthritis, axial
spondyloarthritis, psoriatic arthritis, psoriasis, paediatric
plaque psoriasis, adult and adolescent hidradenitis suppurativa,
Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and
uveitis.
The launch of IMRALDI completes Biogen’s portfolio of three
anti-TNF biosimilars in Europe, with BENEPALITM (etanercept),
a biosimilar referencing Enbrel®2, and
FLIXABITM (infliximab), a biosimilar referencing Remicade®3,
reinforcing the company’s commitment across therapeutic areas in
rheumatology, gastroenterology and dermatology.
“We are proud to be pioneering innovation in biosimilars to help
transform the lives of people in Europe with chronic autoimmune
conditions,” said Ian Henshaw, Global Head of Biosimilars at
Biogen. “With the addition of IMRALDI to our anti-TNF biosimilar
offering, we are increasing physician choice and patient access in
Europe to affordable treatments across disease areas.”
Anti-TNF therapies represent some of the EU’s largest drug
expenditures, costing an estimated €7.69 billion each year from
2011 to 2014.4,5 €10.6 billion could potentially be saved by 2020
through the availability of Biogen’s three anti-TNF biosimilars in
Europe.6
IMRALDI has demonstrated equivalent pharmacokinetics (PK) and
efficacy together with comparable safety and immunogenicity with
the reference product whilst offering a greater shelf life of three
years. With IMRALDI, Biogen has stayed as close as possible to the
classic 40mg/0.8 ml Humira formulation that has been in use for
over a decade, whilst making several improvements to optimize the
patient experience, including an innovative device.
Biogen has nearly 40 years of experience of developing,
manufacturing and commercializing advanced biologic medicines7 and
has a proven supply chain record, reliably supplying approximately
100,000 patients currently under treatment.8 Biogen now has an
EU-approved portfolio that includes two of the most widely
prescribed anti-TNF biosimilars, with BENEPALI available in 25
countries and FLIXABI available in 14 countries.
About IMRALDI Clinical Trials The European
Commission approval was based on a 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
Humira9 and a 52 week Phase III, randomized, double-blind,
multicentre study, in which IMRALDI demonstrated comparable
efficacy and comparable safety and immunogenicity to Humira in
patients with moderate to severe RA despite methotrexate
therapy.10,[11] 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).9 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.
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. One of the
world’s first global biotechnology companies, Biogen was founded in
1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel
Prize winners Walter Gilbert and Phillip Sharp, and today 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
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About Samsung Bioepis Co.,
Ltd.Established in 2012, Samsung Bioepis is a
biopharmaceutical company committed to realizing healthcare that is
accessible to everyone. Through innovations in product development
and a firm commitment to quality, Samsung Bioepis aims to become
the world's leading biopharmaceutical company. Samsung Bioepis
continues to advance a broad pipeline of biosimilar candidates that
cover a spectrum of therapeutic areas, including immunology,
oncology and ophthalmology. Samsung Bioepis is a joint venture
between Samsung BioLogics and Biogen. For more information, please
visit: www.samsungbioepis.com.
Biogen Safe Harbor This press release contains
forward-looking statements, including statements made pursuant to
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, about the potential benefits, safety and
efficacy of IMRALDI; the results of certain Phase I and Phase III
studies of IMRALDI; the potential of Biogen’s commercial business,
including IMRALDI, BENEPALI and FLIXABI; and risks and
uncertainties associated with drug development and
commercialization, including the commercialization of IMRALDI.
These statements may be identified by words such as “aim,”
“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,”
“goal,” “intend,” “may,” “plan,” “possible,” “potential,” “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. Results in early stage clinical
trials may not be indicative of full results or results from later
stage or larger scale clinical trials and do not ensure regulatory
approval. 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 and problems with the manufacturing process for
IMRALDI; 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,
including 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.
Contact:
BIOGEN MEDIA CONTACT:
David Caouette
+1 617 679 4945
david.caouette@biogen.com
BIOGEN INVESTOR CONTACT:
Matt Calistri
+1 617 679 3342
matt.calistri@biogen.com
Samsung Bioepis MEDIA CONTACT:
Andrew Ward/Ben Atwell
+44 20 3727 1000
samsungbioepisUK@fticonsulting.com
____________________________
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 October 20185 Currency exchange rates (rounded). Available
at: www.xe.com. Accessed October 2018.6 Psachoulia E, et al.
2017 Value Health;20(5):A1437 Biogen website. www.Biogen.com. Last
accessed 8th October 20188 Delivering on the Potential of
Biosimilar Medicines. Report by the IMS Institute of Healthcare
Informatics. March 20169 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):1265.10 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).11 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.