Biogen Inc. (Nasdaq: BIIB) and Samsung Bioepis Co., Ltd. today
announced that BYOOVIZ™ (ranibizumab-nuna), a biosimilar
referencing LUCENTIS® (ranibizumab)i has been launched in the
United States. Healthcare provider engagement, promotional
activity, collaborations with professional societies and patient
advocacy groups have commenced and BYOOVIZ will be commercially
available on July 1, 2022, through major distributors across the
U.S. The list price will be $1,130 per single use vial to
administer 0.5mg via intravitreal injection, which is 40% lower
than the current list price of LUCENTIS.
The FDA approved BYOOVIZ in September 2021 for the treatment of
neovascular (wet) age-related macular degeneration (AMD), macular
edema following retinal vein occlusion, and myopic choroidal
neovascularization.
Neovascular (wet) AMD, although less common than dry AMD, is
responsible for the majority of the severe vision loss or blindness
associated with AMD.ii Anti-VEGF therapies have become a standard
of care treatment for wet AMD, but in real-world settings, costs
related with wet AMD treatment often raise challenges in achieving
optimal clinical outcomes.iii Biosimilars, which are biologics with
similar efficacy and comparable safety to reference biologics,iv
have the potential to alleviate the financial burden associated
with current anti-VEGF therapies.
“The launch of BYOOVIZ in the U.S. marks an important moment for
patients, healthcare providers, payers, and the entire healthcare
system. Patients suffering from retinal vascular disorders now have
a more affordable treatment option,” said Ian Henshaw, Senior Vice
President and Global Head of Biosimilars at Biogen. “Our research
with physicians shows cost is cited as a leading barrier to
patients initiating treatment, with one third of patients unable to
afford medication. BYOOVIZ has the potential to expand access to
patients suffering from retinal disorders that can result in
permanent vision loss, while also saving the U.S. healthcare system
billions of dollars.”
"The launch of BYOOVIZ, the first ophthalmology biosimilar in
the U.S. marks a key step towards increasing options and reducing
the financial burden associated with current anti-VEGF treatments,"
said Christopher Hansung Ko, President and Chief Executive Officer,
at Samsung Bioepis. “The priority of Samsung Bioepis is ensuring
patients’ access to the medicines they need, and we will continue
to advance our pipeline to bring better access to biologic
treatments, by leveraging our decade of experience in developing,
manufacturing, and commercializing these important biologics,” he
added.
BYOOVIZ is the first biosimilar launch in the U.S. under the
Biogen and Samsung Bioepis’ partnership. In addition to the U.S.,
BYOOVIZ was also approved as the first ophthalmology biosimilar in
Europe (2021), the United Kingdom (2021), and Canada (2022). The
Biogen and Samsung Bioepis commercialization agreement includes two
ophthalmology biosimilar candidates, BYOOVIZ and SB15, a biosimilar
candidate referencing EYLEA® (aflibercept)v. Samsung Bioepis is
responsible for development, regulatory registration, and
manufacture of the products, while Biogen is responsible for
commercialization.
About BYOOVIZ™ (ranibizumab-nuna)
BYOOVIZ™ (ranibizumab-nuna) injection, for intravitreal use.
BYOOVIZ™ (ranibizumab-nuna) is biosimilar to LUCENTIS®
(ranibizumab injection).
BYOOVIZ™, a vascular endothelial growth factor (VEGF) inhibitor,
is indicated for the treatment of patients with:
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 Biogen
As pioneers in neuroscience, Biogen discovers, develops, and
delivers worldwide innovative therapies for people living with
serious neurological 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, Sir Kenneth Murray, and Nobel Prize winners Walter
Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of
medicines to treat multiple sclerosis, has introduced the first
approved treatment for spinal muscular atrophy, and is providing
the first and only approved treatment to address a defining
pathology of Alzheimer’s disease. Biogen is also commercializing
biosimilars and focusing on advancing the industry’s most
diversified pipeline in neuroscience that will transform the
standard of care for patients in several areas of high unmet
need. In 2020, Biogen launched a bold 20-year, $250 million
initiative to address the deeply interrelated issues of climate,
health, and equity. Healthy Climate, Healthy Lives™ aims to
eliminate fossil fuels across the company’s operations, build
collaborations with renowned institutions to advance the science to
improve human health outcomes, and support underserved
communities. The company routinely posts information that may
be important to investors on our website at www.biogen.com. To
learn more, please visit www.biogen.com and follow Biogen
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.
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.
Media Contact – Biogen
For Investors: Mike Hencke, +1 781 464-2442, IR@biogen.com
For Media: Ashleigh Koss, + 1 908 205 2572,
public.affairs@biogen.com
Media Contact – Samsung BioepisAnna Nayun Kim,
nayun86.kim@samsung.com
______________________
i LUCENTIS® is a registered trademark of Genentechii
American Academy of Ophthalmology. Age-Related Macular Degeneration
Preferred Practice Pattern®. Available at:
https://www.aaojournal.org/article/S0161-6420(19)32091-3/fulltext.
Accessed June 2022.iii Wykoff et al. Optimizing Anti-VEGF Treatment
Outcomes for Patients with Neovascular Age-Related Macular
Degeneration. J Manag Care Spec Pharm, 2018 Feb;24(2-a
Suppl):S3-S15. https://doi.org/10.18553/jmcp.2018.24.2-a.s3iv U.S.
Food and Drug Administration. Biosimilar and Interchangeable
Products. Available at:
https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products.
Accessed June 2022.v EYLEA® is a registered trademark of Regeneron
Pharmaceuticals
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