Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11,
A Proposed Biosimilar Referencing Lucentis® (ranibizumab)
Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for review the Biologics License Application for SB11, a
proposed biosimilar referencing Lucentis®1 (ranibizumab).
Ranibizumab is an anti-VEGF (vascular endothelial growth factor)
therapy for retinal vascular disorders, which are a leading cause
of blindness in the United States.
Biosimilars are products that have been demonstrated to be
similar in efficacy and safety to the originator’s reference
product, with the advantage that they offer cost savings and
promote sustainable access to therapies. Savings in the United
States over the next five years as a result of biosimilars are
projected to exceed $100 billion.3
“The FDA filing acceptance for SB11 brings us a step closer to
our goal of being able to offer affordable treatment options for
people with retinal vascular disorders,” said Hee Kyung Kim, Senior
Vice President and Clinical Sciences Division and Regulatory
Affairs Team Leader, at Samsung Bioepis. “If approved, SB11 will be
a valuable treatment option for people with retinal vascular
disorders, potentially helping millions of people in the U.S.”
“We are encouraged by the FDA’s filing acceptance of SB11, a key
milestone in the process for providing a new potential treatment
option for patients in the United States with retinal vascular
disorders,” said Ian Henshaw, Senior Vice President and Global Head
of Biosimilars at Biogen. “Our biosimilar portfolio aims to ensure
sustainability of healthcare systems by offering broader patient
access to effective and more affordable treatment options.”
In October 2020 the Marketing Authorization Application (MAA)
for SB11 was accepted for review by the European Medicines Agency
(EMA). If approved, SB11 will add to the biosimilars portfolio
developed by Samsung Bioepis and commercialized by Biogen,
including three widely prescribed anti-TNF biosimilars in Europe;
BENEPALI™, IMRALDI™ and FLIXABI™.
Samsung Bioepis announced in November 2019 that it entered into
a new commercialization agreement with Biogen for two ophthalmology
biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept),
in the U.S., Canada, Europe, Japan and Australia.
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,
ophthalmology and hematology. Samsung Bioepis is a joint venture
between Samsung BioLogics and Biogen. For more information, please
visit: www.samsungbioepis.com and follow us on social media –
Twitter, LinkedIn.
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 as well as related therapeutic
adjacencies. 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. Today Biogen has the leading portfolio of medicines
to treat multiple sclerosis, has introduced the first approved
treatment for spinal muscular atrophy, commercializes biosimilars
of advanced biologics and is focused on advancing research programs
in multiple sclerosis and neuroimmunology, Alzheimer’s disease and
dementia, neuromuscular disorders, movement disorders,
ophthalmology, immunology, neurocognitive disorders, acute
neurology and pain.
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.
Safe Harbor
This news release contains forward-looking statements, including
statements made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995, relating to the
potential benefits, safety and efficacy of SB11; the timing and
status of current and future regulatory filings; risks and
uncertainties associated with drug development and
commercialization, including SB11; the potential of Biogen’s
commercial business and pipeline programs, including BENEPALI™,
IMRALDI™, FLIXABI™ and SB11; the anticipated benefits and potential
of Biogen’s collaboration arrangements with Samsung Bioepis;
Biogen’s strategy and plans; and potential cost healthcare savings
related to biosimilars. These forward-looking statements may be
accompanied by words such as “aim,” “anticipate,” “believe,”
“could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will,” “would” 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 without limitation, actual timing and
content of submissions to and decisions made by the regulatory
authorities regarding SB11; regulatory submissions may take longer
or be more difficult to complete than expected; regulatory
authorities may require additional information or further studies,
or may fail or refuse to approve or may delay approval of SB11;
risks of unexpected costs or delays or other unexpected hurdles;
uncertainty of success in the development and potential
commercialization of SB11, 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 SB11 and other unexpected difficulties or
hurdles; the occurrence of adverse safety events; unexpected
concerns that may arise from additional data or analysis; failure
to protect and enforce data, intellectual property and other
proprietary rights and uncertainties relating to intellectual
property claims and challenges; risks of legal actions, regulatory
scrutiny or other challenges to biosimilars; the direct and
indirect impacts of the ongoing COVID-19 pandemic on Biogen’s
business, results of operations and financial condition; 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 U.S. Securities and Exchange
Commission. These statements are based on Biogen’s current beliefs
and expectations and speak only as of the date of this news
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.
References:
1Lucentis is a registered trademark of Genentech, Inc.
2IQVIA Institute for Human Data Science. Biosimilars in the
United States 2020–2024 Competition, Savings, and Sustainability
Institute Report, Sep 29, 2020. Available at:
https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
MEDIA CONTACT SAMSUNG
BIOEPIS:Anna Nayun Kim+82-31-8061-1604nayun86.kim@samsung.com |
|
MEDIA CONTACT BIOGEN:David
Caouette+ 1 617 679 4945public.affairs@biogen.com |
INVESTOR CONTACT BIOGEN:Joe
Mara+1 781 464 2442IR@biogen.com |
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