Physicochemical Properties, Toxicity, and Specific Activity of a Follitropin Alpha Biosimilar
- Authors: Vorob’ev I.I.1, Proskurina O.V.2, Khodak Y.A.1, Gosudarev A.I.3, Semikhin A.S.3, Byrikhina D.V.3, Krasil’shchikova M.S.4, Mel’nik B.S.5, Serebryakova M.V.6, Polzikov M.A.7
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Affiliations:
- Federal Research Centre for Fundamentals of Biotechnology, Russian Academy of Sciences
- All-Russia Scientific Center for Safety Testing of Biologically Active Substances, Ministry of Public Health of the Russian Federation
- N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Russian Ministry of Health
- Shemyakin—Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences
- Institute of Protein Research, Russian Academy of Sciences
- A. N. Belozersky Institute of Physicochemical Biology, Moscow State University
- IVPharma Co.
- Issue: Vol 50, No 11 (2017)
- Pages: 753-760
- Section: Drugs
- URL: https://journals.rcsi.science/0091-150X/article/view/244472
- DOI: https://doi.org/10.1007/s11094-017-1525-3
- ID: 244472
Cite item
Abstract
Comparative analysis of the primary structure of recombinant human follicle-stimulating hormone (r-hFSH) in samples of follitropin alpha biosimilar (FAB) preparation and the reference drug Gonal-F showed they were identical while spectral analysis of their secondary and tertiary structures indicated they were bioequivalent. Analytical results for N-glycans and sialic acids revealed that the main glycan structures were similar and the distributions of the main forms of sialic acids in the compared samples differed insignificantly. Results of in vitro and in vivo biological activity testing confirmed that FAB and Gonal-F were equivalent with respect to WHO standards. Comparative testing of the acute and subacute toxicity did not reveal significant differences between the two drugs and also confirmed they were identical. Thus, the investigation proved that FAB and the reference drug were equivalent with respect to the main physicochemical, pharmacodynamic, and toxicological characteristics.
About the authors
I. I. Vorob’ev
Federal Research Centre for Fundamentals of Biotechnology, Russian Academy of Sciences
Email: mikhail.polzikov@gmail.com
Russian Federation, 33 – 2 Leninskii Prosp., Moscow, 119071
O. V. Proskurina
All-Russia Scientific Center for Safety Testing of Biologically Active Substances, Ministry of Public Health of the Russian Federation
Email: mikhail.polzikov@gmail.com
Russian Federation, 23 Kirov St., Staraya Kupavna, Noginskii District, Moscow Oblast, 142450
Yu. A. Khodak
Federal Research Centre for Fundamentals of Biotechnology, Russian Academy of Sciences
Email: mikhail.polzikov@gmail.com
Russian Federation, 33 – 2 Leninskii Prosp., Moscow, 119071
A. I. Gosudarev
N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Russian Ministry of Health
Email: mikhail.polzikov@gmail.com
Russian Federation, 18 Gamaleya St., Moscow, 123098
A. S. Semikhin
N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Russian Ministry of Health
Email: mikhail.polzikov@gmail.com
Russian Federation, 18 Gamaleya St., Moscow, 123098
D. V. Byrikhina
N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Russian Ministry of Health
Email: mikhail.polzikov@gmail.com
Russian Federation, 18 Gamaleya St., Moscow, 123098
M. S. Krasil’shchikova
Shemyakin—Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences
Email: mikhail.polzikov@gmail.com
Russian Federation, 16/10 Miklukho-Maklaya St., Moscow, 117997
B. S. Mel’nik
Institute of Protein Research, Russian Academy of Sciences
Email: mikhail.polzikov@gmail.com
Russian Federation, 4 Institutskaya St., Pushchino, Moscow Oblast, 142290
M. V. Serebryakova
A. N. Belozersky Institute of Physicochemical Biology, Moscow State University
Email: mikhail.polzikov@gmail.com
Russian Federation, 1/40 Leninskie Gory, Moscow, 119992
M. A. Polzikov
IVPharma Co.
Author for correspondence.
Email: mikhail.polzikov@gmail.com
Russian Federation, 20/2 Nauchnyi Proezd, Moscow, 117246