Samsung Bioepis and Biogen Receive Positive CHMP Opinion for
Aflibercept Biosimilar, OPUVIZ™
- OPUVIZ™, a biosimilar referencing
Eylea1 (aflibercept), is Samsung Bioepis and Biogen’s
second ophthalmology biosimilar to be recommended for marketing
authorization by the European Medicines Agency
INCHEON, South Korea and CAMBRIDGE, Mass., Sept. 20, 2024 (GLOBE
NEWSWIRE) -- 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 OPUVIZ™ 40 mg/mL solution for injection in a
vial, a biosimilar referencing Eylea2 (aflibercept),
also known as SB15.
OPUVIZ has been recommended for approval in adult patients for
the treatment of neovascular (wet) age related macular degeneration
(AMD), visual impairment due to macular oedema secondary to retinal
vein occlusion (RVO; branch or central RVO), visual impairment due
to diabetic macular oedema (DME), and visual impairment due to
myopic choroidal neovascularisation (myopic CNV).
“We are pleased to have our second ophthalmology biosimilar
OPUVIZ recommended for approval in Europe. This marks another
significant milestone for Samsung Bioepis and more importantly for
people living with retinal disorders as we are making a step
forward in enhancing the availability of the essential treatment,”
said Byoungin Jung, Vice President and Regulatory Affairs Team
Leader at Samsung Bioepis. “The positive opinion underscores not
only our commitment to innovation but also ensuring access so that
more patients can benefit from biologic therapies. We will continue
our work to transform the way biologic therapies are brought to
patients and enhance the lives of patients, through our pioneering
and innovative use of science and technology,” she added.
“We are excited about the positive CHMP recommendation for
OPUVIZ in Europe and the potential for it to serve as a meaningful
therapeutic option for individuals impacted by retinal vascular
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.”
The CHMP’s positive opinion was based on a totality of evidence
including analytical, non-clinical data, and clinical data. A
randomized, double-masked, parallel group, multicenter Phase 3
study demonstrated equivalent efficacy and comparable safety,
immunogenicity, and pharmacokinetics (PK) profiles between SB15 and
reference aflibercept (AFL). The primary endpoint was met in terms
of change from baseline in best corrected visual acuity (BCVA) at
week 8, and the 32-week interim analysis and 56-week analysis
demonstrated comparability in other secondary efficacy, safety,
immunogenicity, and PK endpoints between SB15 and
AFL.3, 4
This CHMP’s positive opinion will now be referred to the
European Commission (EC) which will decide whether to grant a
marketing authorization for OPUVIZ. If a marketing authorization is
granted by the EC, OPUVIZ would become the second ophthalmology
biosimilar approved in Europe and fifth biosimilar in the portfolio
developed by Samsung Bioepis with commercialization rights held by
Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™
(etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). 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 OPUVIZ
(SB15, aflibercept), in the U.S., Canada, Europe, Japan and
Australia.
About the SB15 Phase 3
study3
The study is a randomized, double-masked, parallel group phase 3
study conducted at 56 centers in 10 countries from June 2020 to
March 2022, including follow-up through 56 weeks. Of 549
screened participants, 449 participants 50 years and older with
treatment-naive nAMD were randomized 1:1 to receive either SB15 (n
= 224) or AFL (n = 225). At Week 32, patients were re-randomized to
either continue SB15 or AFL, or switch from AFL to SB15 resulting
in three treatment groups; continuing SB15 (SB15/SB15, n=219),
continuing AFL (AFL/AFL, n=108), switching from AFL to SB15
(AFL/SB15, n=111). In total, 425 patients completed up to Week 56.
Key efficacy endpoints of the study were 1) change from baseline in
best corrected visual acuity (BCVA), 2) change from baseline in
central subfield thickness (CST), and 3) proportion of patients
with intra or sub-retinal fluid.
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, nephrology, and endocrinology. For more information,
please visit: www.samsungbioepis.com and follow us on social media
– X, LinkedIn.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that
pioneers innovative science to deliver new medicines to transform
patients’ lives and to create value for shareholders and our
communities. We apply deep understanding of human biology and
leverage different modalities to advance first-in-class treatments
or therapies that deliver superior outcomes. Our approach is to
take bold risks, balanced with return on investment to deliver
long-term growth.
We routinely post information that may be important to investors
on our website at www.biogen.com. Follow us on social
media - Facebook, LinkedIn, X, YouTube.
Biogen Safe Harbor
This news release contains forward-looking statements, including
but not limited to those relating to the potential benefits, safety
and efficacy of SB15; the timing and status of current and future
regulatory filings; risks and uncertainties associated with drug
development and commercialization, including SB15; the potential of
Biogen’s commercial business and pipeline programs, including
BYOOVIZ, BENEPALI, IMRALDI, FLIXABI and SB15; 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 SB15; 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 SB15;
risks of unexpected costs or delays or other unexpected hurdles;
uncertainty of success in the development and potential
commercialization of SB15, 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 SB15 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, results of operations
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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:
- Eylea is a trademark of Regeneron Pharmaceuticals
- European Medicines Agency. Eylea Product Information. Available
at
https://www.ema.europa.eu/en/documents/product-information/eylea-epar-product-information_en.pdf
[Accessed September 2024]
- Woo SJ, Bradvica M, Vajas A, et al. Efficacy and Safety of the
Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular
Degeneration: A Phase 3 Randomized Clinical Trial. JAMA
Ophthalmol. 2023;141(7):668–676.
doi:10.1001/jamaophthalmol.2023.2260
- Sadda SR, Bradvica M, Vajas A, et al. Biosimilar SB15 versus
reference aflibercept in neovascular age-related macular
degeneration: 1-year and switching results of a phase 3 clinical
trial. BMJ Open Ophthalmol. 2023;8(1):e001561.
doi:10.1136/bmjophth-2023-001561
MEDIA CONTACT(S):
Samsung Bioepis
Anna Nayun Kim
nayun86.kim@samsung.com
Yoon Kim
yoon1.kim@samsung.com
Biogen
Jack Cox
+ 1 781 464 3260
public.affairs@biogen.com
INVESTOR CONTACT:
Biogen
Chuck Triano
+1 781 464 2442
IR@biogen.com