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Voskresenskaya A.A.
Cheboksary branch of the S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”;
Postgraduate Doctors’ Training Institute
Sarkizova M.B.
S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”
Khodzhaev N.S.
S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”
Kudlay D.A.
I.M. Sechenov First Moscow State Medical University (Sechenov University);
Lomonosov Moscow State University;
JSC GENERIUM
Kakunina S.A.
S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”
Pozdeyeva N.A.
Cheboksary branch of the S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”;
Postgraduate Doctors’ Training Institute
Biosimilars of ranibizumab in retinal diseases: new possibilities in ophthalmology
Journal: Russian Annals of Ophthalmology. 2025;141(2): 106‑116
Read: 362 times
To cite this article:
Voskresenskaya AA, Sarkizova MB, Khodzhaev NS, Kudlay DA, Kakunina SA, Borozinets AYu, Pozdeyeva NA. Biosimilars of ranibizumab in retinal diseases: new possibilities in ophthalmology. Russian Annals of Ophthalmology.
2025;141(2):106‑116. (In Russ.)
https://doi.org/10.17116/oftalma2025141021106
The development of biological therapeutic agents has provided new opportunities for treating neovascular age-related macular degeneration (nAMD) using humanized monoclonal antibodies (mAbs) targeting vascular endothelial growth factor A (VEGF-A). The emergence of biosimilars of anti-VEGF agents can significantly improve treatment accessibility and its effectiveness by increasing patient adherence. The development of biosimilars involves comparative studies with the original drug to establish equivalence in physicochemical and biological properties, efficacy, and safety. Biosimilar development programs include extensive analytical and preclinical studies to compare structural and functional components with the original bioproduct, and clinical trials are conducted to prove bioequivalence and therapeutic equivalence. The process of development and registration of the biosimilars is strictly regulated and has no significant differences in Russia, the EU and the US. Currently, more than 10 biosimilars of ranibizumab have been approved worldwide, in Russia it is the drug Laxolan (AO GENERIUM). The introduction of a domestic biosimilar of ranibizumab into clinical practice allows reduction of the costs of retinal disease treatment while maintaining the efficacy and safety of antiangiogenic therapy.
Authors:
Voskresenskaya A.A.
Cheboksary branch of the S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”;
Postgraduate Doctors’ Training Institute
Sarkizova M.B.
S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”
Khodzhaev N.S.
S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”
Kudlay D.A.
I.M. Sechenov First Moscow State Medical University (Sechenov University);
Lomonosov Moscow State University;
JSC GENERIUM
Kakunina S.A.
S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”
Pozdeyeva N.A.
Cheboksary branch of the S.N. Fedorov National Medical Research Center “MNTK “Eye Microsurgery”;
Postgraduate Doctors’ Training Institute
Received:
19.02.2025
Accepted:
04.03.2025
List of references:
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