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Physicochemical Properties, Toxicity, and Specific Activity of a Follitropin Alpha Biosimilar

Pharmaceutical Chemistry Journal volume 50, pages 753–760 (2017)Cite this article

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.

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Authors and Affiliations

  1. Federal Research Centre for Fundamentals of Biotechnology, Russian Academy of Sciences, 33 – 2 Leninskii Prosp., Moscow, 119071, Russia

    I. I. Vorob’ev & Yu. A. Khodak

  2. All-Russia Scientific Center for Safety Testing of Biologically Active Substances, Ministry of Public Health of the Russian Federation, 23 Kirov St., Staraya Kupavna, Noginskii District, Moscow Oblast, 142450, Russia

    O. V. Proskurina

  3. N. F. Gamaleya Federal Research Centre for Epidemiology and Microbiology, Russian Ministry of Health, 18 Gamaleya St., Moscow, 123098, Russia

    A. I. Gosudarev, A. S. Semikhin & D. V. Byrikhina

  4. Shemyakin—Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 16/10 Miklukho-Maklaya St., Moscow, 117997, Russia

    M. S. Krasil’shchikova

  5. Institute of Protein Research, Russian Academy of Sciences, 4 Institutskaya St., Pushchino, Moscow Oblast, 142290, Russia

    B. S. Mel’nik

  6. A. N. Belozersky Institute of Physicochemical Biology, Moscow State University, 1/40 Leninskie Gory, Moscow, 119992, Russia

    M. V. Serebryakova

  7. IVPharma Co., 20/2 Nauchnyi Proezd, Moscow, 117246, Russia

    M. A. Polzikov

Authors
  1. I. I. Vorob’ev
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  2. O. V. Proskurina
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  3. Yu. A. Khodak
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  4. A. I. Gosudarev
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  5. A. S. Semikhin
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  6. D. V. Byrikhina
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  7. M. S. Krasil’shchikova
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  8. B. S. Mel’nik
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  9. M. V. Serebryakova
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  10. M. A. Polzikov
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Correspondence to M. A. Polzikov.

Additional information

Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 50, No. 11, pp. 35 – 42, November, 2016.

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Vorob’ev, I.I., Proskurina, O.V., Khodak, Y.A. et al. Physicochemical Properties, Toxicity, and Specific Activity of a Follitropin Alpha Biosimilar. Pharm Chem J 50, 753–760 (2017). https://doi.org/10.1007/s11094-017-1525-3

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  • DOI: https://doi.org/10.1007/s11094-017-1525-3

Keywords

  • recombinant human follicle-stimulating hormone (r-hFSH)
  • preclinical investigation
  • Gonal-F