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Pharmaceutical Chemistry Journal

, Volume 50, Issue 11, pp 753–760 | Cite as

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

  • I. I. Vorob’ev
  • O. V. Proskurina
  • Yu. A. Khodak
  • A. I. Gosudarev
  • A. S. Semikhin
  • D. V. Byrikhina
  • M. S. Krasil’shchikova
  • B. S. Mel’nik
  • M. V. Serebryakova
  • M. A. PolzikovEmail author
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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.

Keywords

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

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Copyright information

© Springer Science+Business Media New York 2017

Authors and Affiliations

  • I. I. Vorob’ev
    • 1
  • O. V. Proskurina
    • 2
  • Yu. A. Khodak
    • 1
  • A. I. Gosudarev
    • 3
  • A. S. Semikhin
    • 3
  • D. V. Byrikhina
    • 3
  • M. S. Krasil’shchikova
    • 4
  • B. S. Mel’nik
    • 5
  • M. V. Serebryakova
    • 6
  • M. A. Polzikov
    • 7
    Email author
  1. 1.Federal Research Centre for Fundamentals of BiotechnologyRussian Academy of SciencesMoscowRussia
  2. 2.All-Russia Scientific Center for Safety Testing of Biologically Active SubstancesMinistry of Public Health of the Russian FederationStaraya Kupavna, Noginskii DistrictRussia
  3. 3.N. F. Gamaleya Federal Research Centre for Epidemiology and MicrobiologyRussian Ministry of HealthMoscowRussia
  4. 4.Shemyakin—Ovchinnikov Institute of Bioorganic ChemistryRussian Academy of SciencesMoscowRussia
  5. 5.Institute of Protein ResearchRussian Academy of SciencesPushchinoRussia
  6. 6.A. N. Belozersky Institute of Physicochemical BiologyMoscow State UniversityMoscowRussia
  7. 7.IVPharma Co.MoscowRussia

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