International standards for monoclonal antibodies for assessing the biological activity of medicines: A status update

Scientific relevance. The clinical effects and the expiration of patents for original (reference) biotechnological medicines based on monoclonal antibodies (mAbs) stimulated the development of biosimilar mAbs. The quality profile of a biosimilar mAb should correspond to the quality of the reference...

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Bibliographic Details
Main Authors: L. A. Gayderova, N. A. Alpatova, S. L. Lysikova, M. L. Baykova, A. M. Guskov, D. A. Zubkov
Format: Article
Language:Russian
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2023-12-01
Series:Биопрепараты: Профилактика, диагностика, лечение
Subjects:
Online Access:https://www.biopreparations.ru/jour/article/view/532