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
(US).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 US is a monumental milestone for
people living with retinal vascular disorders in the US," 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 US. 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 US,” 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 US 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®viii (aflibercept), 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 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 US, 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 US 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,ix
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.x
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
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
_________________________________________________________________
i LUCENTIS® is a registered trademark of
Genentech
ii 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.s1959
iii “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
Pharmaceuticals
ix “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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