FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11),
LUCENTIS® Biosimilar (ranibizumab-nuna)
Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today
announced that the U.S. Food and Drug Administration (FDA) has
approved BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing
LUCENTIS® (ranibizumab)i for the treatment of neovascular (wet)
age-related macular degeneration (AMD), macular edema following
retinal vein occlusion (RVO), and myopic choroidal
neovascularization (mCNV).
Ranibizumab is an anti-vascular endothelial growth factor (VEGF)
therapy that prevents vision loss in patients with retinal vascular
disorders which can cause irreversible blindness or visual
impairments in adults in the United States (U.S.). ii,iii,iv,v
BYOOVIZ™ is the first ophthalmology biosimilar approved 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. vi Savings in the United
States over the next five years from 2020 to 2024 as a result of
biosimilars are projected to exceed $100 billion. vii
"In the United States, approximately 11 million people are
affected with AMD and the prevalence of advanced AMD is growing due
to the aging population. The approval of the first ranibizumab
biosimilar in the U.S. is a monumental milestone for people living
with retinal vascular disorders in the U.S.," said Kyung-Ah Kim,
Senior Vice President and Development Division Leader, at Samsung
Bioepis. “The approval of BYOOVIZ™ underscores our continued
commitment to providing valuable treatment options for people who
do not have access to life-enhancing biologic medicines around the
world,” she added.
“We are very excited to be able to open a new chapter with the
approval of BYOOVIZ™ in the U.S. This approval represents a great
step toward the advancement of a new therapeutic option addressing
debilitating disease progression of patients with retinal vascular
disorders in the U.S.,” said Ian Henshaw, Senior Vice President and
Global Head of Biosimilars at Biogen. “Biosimilars could help
broaden patient access to more affordable treatments and generate
healthcare savings to offset rising costs of these complex diseases
while ensuring sustainability of healthcare systems.”
In addition to the U.S. approval, BYOOVIZ™ was approved in
Europe, including 27 European Union (EU) member countries on August
18, 2021 and the United Kingdom on August 31, 2021.
Samsung Bioepis and Biogen entered into a commercialization
agreement for two ophthalmology biosimilar candidates, SB11, a
biosimilar candidate referencing LUCENTIS® (ranibizumab) and SB15,
a biosimilar candidate referencing EYLEA® (aflibercept) vi, in
November 2019. Developed by Samsung Bioepis, SB11 will
be commercialized under the brand name BYOOVIZ™ by Biogen in the
United States. Pursuant to a global license agreement entered into
with Genentech, Samsung Bioepis and Biogen will have freedom to
market SB11 in the United States as of June 2022, i.e., before
expiration of Genentech’s applicable supplementary patent
certificates (SPCs), and elsewhere in other territories after
expiration of Genentech’s SPCs.
The FDA approval of BYOOVIZ™ was based on a totality of evidence
including analytical, non-clinical data, and clinical data. In a
randomized, double-masked, parallel group, multicenter Phase 3
study of SB11, the efficacy, safety, pharmacokinetics, and
immunogenicity of SB11 was compared to reference ranibizumab in
patients with wet AMD. 705 patients were randomized (1:1) to
receive SB11 or reference ranibizumab in monthly injections (0.5
mg), and 634 patients continued to receive treatment up to week 48.
The Least Squares (LS) mean change in best corrected visual acuity
(BCVA) from baseline at week 52 was 9.79 letters for SB11, compared
with 10.41 letters for reference ranibizumab (difference: -0.62,
[90% CI: -2.092, 0.857]). The LS mean change in central subfield
thickness (CST) was −139.55 μm for SB11 vs −124.46 μm for reference
ranibizumab (difference: -15.09, [95% CI, -25.617, -4.563]). PK,
safety including incidence of treatment-emergent adverse events,
and the immunogenicity profile of SB11 and reference ranibizumab
were comparable at all timepoints up to week 52.
BYOOVIZ™ (ranibizumab-nuna) is Samsung Bioepis’ fifth biosimilar
approved in the U.S., following the approval of RENFLEXIS®
(infliximab-abda) in April 2017, ONTRUZANT® (trastuzumab-dttb) in
January 2019, ETICOVO® (etanercept-ykro) in April 2019, and
HADLIMA™ (adalimumab-bwwd) in July 2019.
Please see full indications and important safety information for
BYOOVIZ™ below.
About BYOOVIZ™ (ranibizumab-nuna)
BYOOVIZ™ is approved in the U.S. for the following
indications:
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Myopic Choroidal Neovascularization (mCNV)
Select Important Safety Information
WARNING AND PRECAUTIONS
Endophthalmitis and retinal detachments may occur following
intravitreal injections. Patients should be monitored following the
injection.
Increases in intraocular pressure (IOP) have been noted both
pre- and post-intravitreal injection.
There is a potential risk of arterial thromboembolic events
following intravitreal use of VEGF inhibitors.
Please see Prescribing Information for BYOOVIZ™
(ranibizumab-nuna) HERE
About neovascular (wet) age-related macular degeneration
(AMD)
Age-related macular degeneration (AMD) is the leading cause of
irreversible blindness in adults over 50 years old. Approximately
11 million individuals are affected with AMD in the US alone. Wet
AMD is responsible for 80 to 90 % of all AMD-related blindness.
iii,vii
About macular edema following retinal vein occlusion
(RVO)
Central retinal vein occlusion (RVO) is a common cause of
retinal disease that can cause vision loss. Vision loss from CRVO
is commonly caused by macular edema, which occurs when fluid leaks
into the macula (center of the retina) as a result of blocked blood
vessel.vii
About myopic choroidal neovascularization
(mCNV)
Myopia is one of the most common causes of vision impairment,
and one of the most feared complications of myopia is the
development of choroidal neovascularization (CNV). Myopic CNV can
occur in patients with any degree of myopia, even in the absence of
characteristic degenerative retinal changes. v
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, hematology, endocrinology, and gastroenterology. 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, neuropsychiatry, immunology, acute neurology and
neuropathic pain.
We routinely post information that may be important to investors
on our website at www.biogen.com.
Follow us on social media Twitter, LinkedIn, Facebook, YouTube.
To learn more, please visit www.biogen.com and follow us on social
media - Twitter, LinkedIn, Facebook, YouTube.
Biogen 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 BYOOVIZ™; the timing and
status of current and future regulatory filings; risks and
uncertainties associated with drug development and
commercialization, including BYOOVIZ™; 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, uncertainty of
success in the commercialization of BYOOVIZ™, 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 BYOOVIZ™ 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.
Media Contact - Samsung Bioepis Co.
Anna Nayun Kim: nayun86.kim@samsung.com
Media Contact - Biogen For Investors: Mike
Hencke, +1 781 464-2442, IR@biogen.com For Media: Allison Parks, +1
781 464-3260, public.affairs@biogen.com
References:
i LUCENTIS® is a registered trademark of Genentechii
Spitzer MS, Ziemssen F, Bartz-Schmidt KU, Gelisken F, Szurman P.
Treatment of age-related macular degeneration: focus on
ranibizumab. Clin Ophthalmol. 2008;2(1):1-14.
doi:10.2147/opth.s1959iii “What Is Macular Degeneration?” American
Academy of Ophthalmology website. Jan 26, 2021. Available at:
https://www.aao.org/eye-health/diseases/amd-macular-degeneration.
Accessed July 2021.iv “Untangling Retinal Vein Occlusion” EyeNet
Magazine, November 2013. Available at:
https://www.aao.org/eyenet/article/untangling-retinal-vein-occlusion.
Accessed July 2021.v “Myopic Choroidal Neovascularization.”
Ophthalmic Pearls, vol. March 2020. Available at:
https://www.aao.org/eyenet/article/myopic-choroidal-neovascularization.
Accessed July 2021. vi “Biosimilar and Interchangeable Products.”
U.S. Food and Drug Administration website. Oct 23, 2017. Available
at:
https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products.
Accessed September 2021.vii IQVIA 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.
Accessed September 2021.viii EYLEA® is a registered trademark of
Regeneron Pharmaceuticalsix “Blindness Due to Age-Related Macular
Degeneration Should Not be Considered an Inevitability” [News
Release]. American Academy of Ophthalmology. Feb 06, 2014.
Available at:
https://www.aao.org/newsroom/news-releases/detail/blindness-due-to-agerelated-macular-degeneration-s.
Accessed July 2021.x “What Causes Macular Edema?” American
Academy of Ophthalmology website. Oct. 22, 2020. Available at:
https://www.aao.org/eye-health/diseases/macular-edema-cause.
Accessed July 2021.
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