- BYOOVIZ™ becomes the first ophthalmology biosimilar to gain FDA approval in
the United States
INCHEON,
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
BYOOVIZ™ is the first ophthalmology biosimilar approved in
"In
“We are very excited to be able to open a new chapter with the approval of BYOOVIZ™ in the
In addition to the
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
Please see full indications and important safety information for BYOOVIZ™ below.
About BYOOVIZ™ (ranibizumab-nuna)
BYOOVIZ™ is approved in the
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
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Established in 2012,
About Biogen
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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
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
Media Contact -
Anna Nayun Kim: nayun86.kim@samsung.com
Media Contact - Biogen
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References:
i LUCENTIS® is a registered trademark of
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?”
iv “Untangling Retinal Vein Occlusion”
v “Myopic Choroidal Neovascularization.” Ophthalmic Pearls, vol.
vi “Biosimilar and Interchangeable Products.”
vii
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].
x “What Causes Macular Edema?”
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