Biogen and Samsung Bioepis Announce European Launch of IMRALDI™(adalimumab), Solidifying Leadership in European Anti-TNF Market
17.10.2018 09:18:00 EEST | Business Wire | Press release
Biogen (Nasdaq:BIIB) and Samsung Bioepis Co., Ltd. today announced the European launch of IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA®. Starting today, IMRALDI™ will begin launching in major markets across Europe.
The launch of IMRALDI™ marks a significant milestone for Biogen and Samsung Bioepis, as the adalimumab product is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe. BENEPALI™ (etanercept) and FLIXABI™ (infliximab) were approved in 2016, and have approximately 100,000 patients currently under treatment with more than 6 million doses administered across 25 and 14 countries, respectively.ii
“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, Head of Biogen’s Biosimilars Unit.
“The launch of IMRALDI marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems. We hope IMRALDI will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market,” said Sang-Jin Pak, Chief Operating Officer, Samsung Bioepis. “In just six years, Samsung Bioepis has successfully developed the industry’s leading portfolio of anti-TNF biosimilars with a strong pipeline of further biosimilar candidates currently under development.”
“We are proud of our collaboration with Biogen, which brings together the development expertise of Samsung Bioepis with the commercial excellence of Biogen for the benefit of patients across Europe.”
The European Commission (EC) approved IMRALDI™ in August 2017 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.iii
The EC approval was based on data derived from a randomized,
double-blind 52-week Phase 3 study, in which 544 patients with moderate
to severe rheumatoid arthritis despite methotrexate (MTX) therapy were
randomized to receive either SB5 or the adalimumab reference product
(ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group
versus 72.2% in the ADL group. The safety profile of SB5 was comparable
to ADL up to Week 24. At Week 24, 254 patients receiving ADL were
re-randomized in a 1:1 ratio to continue on ADL or transitioned to SB5,
and 254 patients receiving SB5 continued to receive SB5. Up to Week 52,
the efficacy, safety and immunogenicity profiles remained comparable
between all three treatment groups. There were no treatment emergent
issues or clinically relevant immunogenicity precipitated by alternating
subjects between treatments.iv v
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 www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
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 3 studies of IMRALDI;
the potential of Biogen’s commercial business, including IMRALDI,
BENEPALI and FLIXABI; risks and uncertainties associated with drug
development and commercialization, including the commercialization of
IMRALDI; and market acceptance of biosimilars and related healthcare
system matters. 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.
# # #
i Humira® is a registered trademark of AbbVie
Biotechnology Ltd.
ii Biogen data on file – ex-factory
sales
iii
https://www.ema.europa.eu/medicines/human/EPAR/imraldi
iv
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.
v 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).
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Contact information
BIOGEN MEDIA CONTACT:
David Caouette
+1 617 679 4945
david.caouette@biogen.com
or
SAMSUNG
BIOEPIS MEDIA CONTACT:
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com
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