Inicio Módulos de aprendizaje
Módulos de aprendizaje
Biocomparables vs. genéricos
¿Es un biocomparable?
Vías de regulación
Diseño de estudio clínico
Referencias 1. Sekhon B, Saluja V. Biosimilars: an overview. Biosimilars 2011:11-11. 2. Mellstedt H. The challenge of biosimilars. Annals of Oncology. 2008; 19:411-419. 3. Dossier: terapias biologicas inmunológicas: innovación y cambios. MSD salud. 4. Mysler E, Pineda C, Horiuchi T, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies og biologics in rheumatology. Rheumatol Int. 2016; 36:613-625. 5. FDA. Scientific Considerations in Dermonstrating Biosimilarity to a Reference Product. Guidance for Insdustry. 2015. Acceso electrónico en: 6. Mc Camish M, Woollett G. The State of the Art in the Development of Biosimilars. Clinical pharmacology & Therapeutics. 2012;91(3) :405-417. 7. Jaymi F. Lee, Jason B. Litten & Gustavo Grampp. Comparability and biosimilarity: considerations for the healthcare provider. Current Medical Research and Opinion. 2012; 28(6):1053-1058. 8. FDA. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product Guidance for a Industry. Acceso electrónico en: htttp:// 9. ICH Expert Working Group. DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11.2012. 10. Scheinberg M, Kay J. The advent of biosimilar therapies in rheumatology-"O Brave New World". Nat. Rev. Rheumatol. 2012;8:430-436. 11. Kozlowski S. US FDA Perspectives on Biosimilar Biological Products. 2014 Biotechnology Technology Summit BBR University of Maryland Rockville, MD. 12. Ventola L. Biosimilars, Part 1: Proposed Regulatory Criteria for FDA Approval. P&T. 2013; 38(5):271-284. 13. European Medicines Agency. Guideline on similar biological medical products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. Acceso electrónico en 14. Lai Z, La Noche A. Key design considerations on comparative efficacy studies for biosimilars: adalimumab as an example. RMD Open 2016;2:000154. 15. Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know. Blood. 2012; 120(26): 5111-5117. 16. FDA. Assay Development and Validation for Immunogenicity Testing of therapeutic Protein Products. Guidance for Industry. Acceso electrónico en: 17. Ben-Horin S, Yavzori M, Benharl, et al. Cross-inmunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima. Gut. 2015;0:1-7. 18. Pineda C, Castañeda Hernández G, Jacobs I, et al. Assessing the inmunogenicity of Biopharmaceuticals. BioDrugs. 2016;30:195-206. 19. Kaur P, Chow V, Zhang N, et al. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab. Ann Rheum Dis 2017;76:526-533. 20. WHO. GUIDELINES ON EVALUATION OF SIMILAR BIOTHERAPEUTIC PRODUCTS (SBPs). 2009. 21. Declerck P. Biologicals and biosimilars: a review of the science and its implications. Generics and Biosimilars Initiative Journal (GaBi Journal). 2012;1(1):13-6. 22. Schellekens H. Biosimilar therapeutics-what do we need to consider?. NDT Plus. 2009;2(1):27-36. 23. Krese GB. Biosimilars - Science, status, and strategic perspective. European Journal of Pharmaceutics and Biopharmaceutics. 2009;72:479-486. 24. Roger S. Biosimilars: How similar or dissimilar are they?. NEPHROLOGY 2006;11:341-346. 25. Departament Of Health & Human Services. Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993). 26. Ramanan S, Gramoo G. Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing. BioDrugs. 2014: ©2020 AMGEN Inc. Todos los derechos reservados.
© 2020 Amgen. México S.A. de C.V. Todos los derechos reservados.