Guidelines of research biosimilar drugs

GLP, ICH, архивирование данных, биоаналог, доклинические исследования, доклиническое исследование иммуногенности, иммуногенность, инновационный биологический лекарственный препарат, инсулин, интерферон бета, исследования безопасности, исследования эффективности, исследования фармакокинетики, клинические исследования, моноклональные антитела, оригинальный биологический лекарственный препарат, пострегистрационные исследования, пострегистрационный мониторинг безопасности, правила проведения исследований, сообщения о серьёзных нежелательных реакциях, токсикологические исследования, токсичность, фармакодинамика, фармакодинамические исследования, фармакокинетические исследования, фармаконадзор, эквивалентность

1. EMA. Guideline on Similar Biological Medicinal Products. The European Medicines Agency Evaluation of Medicines for Human Use; EMA: London, UK, 2005; EMEA/CHMP/437/04.

2. EMA. Revision of the Guideline on Similar Biological Medicinal Product; EMA: London, UK, 2013; CHMP/437/04 Rev 1.

3. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1); EMA: London, UK, 2014; EMA/CHMP/BWP/247713/2012.

4. EMA. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues; EMA: London, UK, 2006; EMEA/CHMP/BMWP/42832.

5. EMA. Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues (Draft); EMA: London, UK, 2013; EMEA/CHMP/BMWP/42832/2005 Rev. 1.

6. EMA. Guideline on Non-Clinical and Clinical Development of Similar Biological Medicinal Products Containing Low-Molecular-Weight- Heparins; EMA: London, UK, 2009; EMEA/CHMP/BMWP/118264/07.

7. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant erythropoietin’s (Revision); EMA: London, UK, 2010; EMEA/CHMP/BMWP/301636/2008 Corr.

8. EMA. Non-Clinical and Clinical Development of Similar Medicinal Products Containing Recombinant Interferon Alfa; EMA: London, UK, 2009; EMEA/CHMP/BMWP/102046/06.

9. EMA. Guideline on Similar Biological Medicinal Products Containing Interferon Beta; EMA: London, UK, 2013; EMA/CHMP/ BMWP/652000/2010.

10. EMA. Guideline on similar biological medicinal products containing monoclonal antibodies (CHMP/BMWP/403543/2010).

11. EMA. Concept Paper On Similar Biological Medicinal Products Containing Recombinant Follicle Stimulation Hormone; EMA: London, UK, 2010; EMA/CHMP/BMWP/94899/2010.

12. Guideline on development, production, characterization and specifications for monoclonal antibodies and related substances (EMEA/CHMP/ BWP/157653/07).

13. Guideline on bioanalytical method validation (EMEA/CHMP/EWP/192217/2009).

14. Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins (CHMP/BMWP/14327).

15. Guideline on the clinical investigation of the pharmacokinetics of therapeutic proteins (CHMP/EWP/89249/2004).

16. Guideline on the investigation of bioequivalence (CHMP/EWP/QWP/1401/98).

17. Guideline on the evaluation of anticancer medicinal products in man (CHMP/EWP/205/95).

18. Guideline on the choice of a non-inferiority margin (EMEA/CPMP/EWP/2158/99).

19. Guideline on Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use (EMA/CHMP/BMWP/86289/2010). FDA

20. FDA. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product; FDA: Silver Spring, USA, 2012.

21. FDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; FDA: Silver Spring, USA, 2012.

22. FDA. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; FDA: Silver Spring, USA, 2012. Pharmaceuticals 2012, 5 368.

23. FDA. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product; FDA: Silver Spring, USA, 2014. ICH

24. ICH guideline S 6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals (EMA/CHMP/ICH/731268/1998).

25. ICH E2E Note for guidance on Planning Pharmacovigilance Activities (CPMP/ICH/5716/03).

26. ICH E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (CPMP/ICH/377/95).

27. ICH E10 Choice of Control Group in Clinical Trials (CPMP/ICH/364/96).

28. ICH Q2: Validation of analytical procedures: text and methodology.

29. ICH Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.

30. ICH Q5E: Comparability of Biotechnological/Biological Products.

31. ICH Q6B: Specifications: Test procedures and acceptance criteria for biotechnological/biological products.

32. ICH Q8: Pharmaceutical. Development. ВОЗ

33. WHO. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs); WHO: Geneva, Switzerland, 2009. Другие страны

34. Authority of the Minister of Health. Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs); Health Canada: Ottawa, Canada, 2010.

35. MHLW. Guidelines for the Quality, Safety and Efficacy Assurance of Follow-On Biologics; MHLW: Tokyo, Japan, 2009.

36. KFDA. Korean Guidelines on the Evaluation of Similar Biotherapeutic Products (SBPs); KFDA: Chungcheongbuk-do, Korea, 2009.

37. Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India; Department of Biotechnology, Ministry of Science & Technology; Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, New Delhi, 2012.