Prospects for development and clinical use of biosimilars in ukraine
The concepts of a biopharmaceutical drug and a biosimilar have been described. Commercial advantages of the biosimilars use have been shown, expiration of terms of patents for a number of biopharmaceuticals is reported. The basic requirements of EMEA to research of biosimilars containing G-CSF (filgrastim) and epoetin are given. The analysis of key moments of biosimilars application such as pre-clinical and clinical studies, immunogenicity, use of trade mark, effective pharmacovigilance has been conducted. It has been noted that in the European Union, pharmaceutical companies must submit a risk-management plan to the agency at the time of application for a marketing authorization of new active pharmaceutical ingredients and biosimilars. The analysis conducted has revealed a significant price affordability of biosimilars manufactured by domestic pharmaceutical companies compared to the original drugs. There are pharmaceutical companies that can provide a full cycle of biosimilar manufacture in Ukraine. Introduction into production of highly effective and safe domestic biosimilars for the treatment of priority diseases (diabetes, anemia, cancer pathology, immunopathology) will allow to increase competitiveness and persistent development of domestic pharmaceutical companies. Among the most serious problems in manufacture and consumption of biosimilars in Ukraine there are the lack of funding, the absence of drug reimbursement of the cost to the public and others. It has been emphasized that the results of pre-clinical and clinical studies must show the equivalence of pharmacodynamic, pharmacokinetic and toxicological properties of a biosimilar to the original drug, equivalence of its therapeutic efficiency, safety profile, tolerance in relation to the original drug. The final evidence of biosimilar characteristics will be provided by strict pharmacovigilance.
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Генерики и биосимиляры в России и странах СНГ: уроки настоящего и взгляд в будущее // Аптека. – 2012. – №37. – Режим доступа: www.apteka.ua
Проценко М.В., Ягудина Р.И. // Фармакоэкономика. – 2010. – Т. 3, №4. – С. 13-21.
CHMP (Committee for Medicinal Products for Human Use) (2005) Guideline on risk management systems for medicinal products for human use. European Medicines Agency document EMEA/CHMP/96268/ 2005 – Режим доступа: www.ema.europa.eu
European Medicine Agency Evaluation of Medicines for Human Use. Assessment report for Tevagrastim. EMEA/503293/2008. – Режим доступа: www.ema.europa.eu
European Medicine Agency Evaluation of Medicines for Human Use. Assessment report for Ratiograstim EMEA/502481/2008. – Режим доступа: www.ema.europa.eu
European Medicine Agency Evaluation of Medicines for Human Use. Assessment report for Zarzio. EMEA/CHMP/651339/2008. – Режим доступа: www.ema.europa.eu
European Medicines Agency. Guidance on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor. 2006. – Режим доступа: www.ema.europa.eu
Gascon Pere // Targ. Oncol. – 2012. – Vol. 7. – P. 29-34.
Heinemann L., Hompesch M. // J. of Diabetes Sci. and Technol. – 2011. – Vol. 5. – P. 741-754.
Mellstedt H., Niederwieser D., Ludwig H. // Ann. of Oncol. – 2008. – Vol. 19. – P. 411-419.
Rovira Joan, Espín Jaime, García Leticia, Antonio Olry de Labry. The impact of biosimilars’ entry in the EU market. – Режим доступа: ec.europa.eu
Schellekens H., Jiskoot W. // Nat. Biotechnol. – 2006. – Vol. 24. – P. 613-614.
The Commission of the European Communities (2003) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use // In: Official Journal of the European Union. – L159. –
Р. 46-94. – Режим доступа: http://eur-lex.europa.eu.
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