Samsung Bioepis and Biogen Receive Positive CHMP Opinion for
Ranibizumab Biosimilar, BYOOVIZ™
Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today
announced that the European Medicines Agency’s (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis®1
(ranibizumab), also known as SB11. Ranibizumab is an anti-VEGF
(vascular endothelial growth factor) for retinal vascular
disorders, which are a leading cause of blindness. BYOOVIZ has been
recommended for approval for the treatment of neovascular (wet)
age-related macular degeneration (AMD), visual impairment due to
diabetic macular oedema (DME), proliferative diabetic retinopathy
(PDR), visual impairment due to macular odemea secondary to retinal
vein occlusion (branch RVO or central RVO) and visual impairment
due to choroidal neovascularization (CNV) in the European Union
(EU).
The CHMP’s positive opinion will now be referred to the European
Commission (EC), which will decide whether to grant a marketing
authorization for BYOOVIZ. If a marketing authorization is granted
by the EC, BYOOVIZ would be added 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™.
“We are very proud to see BYOOVIZ becoming the
first biosimilar of ranibizumab to be recommended for approval in
Europe. This marks an important milestone for our company, as this
is one step forward to expanding patient access to treatments for
retinal vascular disorders,” said Kyung-Ah Kim, Senior Vice
President and Development Division at Samsung Bioepis. “We will
continue our efforts to develop and deliver high-quality and proven
biologic medicines to more patients and healthcare systems in
Europe.”
“Retinal vascular disorders affect millions of people, and we
believe BYOOVIZ has the potential to be a meaningful therapeutic
offering for patients living with these disorders,” said Ian
Henshaw, Global Head of Biosimilars at Biogen. “Biosimilars could
help broaden access and offer significant healthcare savings
through the treatment of these complex and often debilitating
ophthalmic diseases.”
This positive CHMP opinion on BYOOVIZ was based on a Phase 3
clinical study that demonstrated equivalence in efficacy for both
primary endpoints. The adjusted treatment differences between
groups were within predefined equivalence margins for mean changes
from baseline in both best corrected visual acuity (BCVA) and in
central subfield thickness (CST). The improvements in the primary
efficacy outcomes remained stable and appeared comparable between
treatment groups at all time points up to week 52.
In November 2019, Samsung Bioepis and Biogen announced that they
had entered into a commercialization agreement for two
ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab)
and SB15 (aflibercept), in the U.S., Canada, Europe, Japan and
Australia.
Additionally, the Biologics License Application for SB11 was
accepted for review by the U.S. Food and Drug Administration in
November 2020.
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 and endocrinology. 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, neuropsychiatry, immunology, acute neurology and
neuropathic 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.
Media Contact - Samsung Bioepis
[EU news release] Yoon Kim: +82-31-8061-1783,
yoon1.kim@samsung.com
[US news release] Anna Nayun Kim: 82+31-8061-1604,
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
Biogen (TG:IDP)
Historical Stock Chart
From Jun 2024 to Jul 2024
Biogen (TG:IDP)
Historical Stock Chart
From Jul 2023 to Jul 2024