What dermatologists should know about biologics and biosimilars
Keywords:
biologics, biosimilars, regulationAbstract
In the last few years, biologics have turned into one of the main alternatives for the treatment of diverse serious illnesses and their future use in other diseases is even more promising. Although these products are important in therapeutics as a novel therapeutical armamentarium, their cost of production and development has limited their access to all patients, particularly in developing countries. Therefore, in the last decade, and in response to patent expiration of different biologics, the introduction to the pharmaceutical market of what today are named biosimilars has been propitiated.
Taking into consideration that yearly the introduction of biosimilar medicines in the therapeutic dermatologic arsenal will increase in the following years, in this review article we describe the process of production of biologics, as well as their differences with biosimilars, and some regulation issues.
Author Biography
Gloria Sanclemente
Médica dermatóloga, M.Sc. en Epidemióloga Clínica, candidata a Ph.D., Universidad Autónoma de Barcelona, España; Grupo Cochrane Iberoamericano, España; coordinadora, Grupo de Investigación Dermatológica; profesora asociada, Facultad de Medicina, Universidad de Antioquia Medellín, Colombia
References
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24. Chu R, Pugatch M. Biogenerics or biosimilars: Discussing the present, considering the future. Stockholm, 2009. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.stockholm-network.org/downloads/publications/Biosimilars_FINAL.pdf.
25. Patent Docs. Clinical Trials are top issue at FDA hearings on biosimilars. USA, 2010. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.patentdocs.org/2010/11/clinical-trial-requirements-are-top-issue-at-fda-hearings-onbiosimilars.html.
26. Caicedo L. Biosimilares: otro reto de la medicina del futuro. Bogotá, Colombia, 2007. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.biofarmacos.org/files/contenido/Biosimilares%20otro%20reto%20de%20la%20medicina%20del%20futuro.pdf.
27. Colprensa. Colombia avanza en la reglamentación de medicamentos biotecnológicos. Cartagena, Colombia 2011. Fecha de consulta: 4 de abril de 2011. Disponible en: http://www.eluniversal.com.co/cartagena/vida-sana/colombia-avanza-enla-reglamentacion-de-medicamentos-biotecnologicos-18642.
2. United States Patent and Trademark Office. Patents. Washington, USA, 2010. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.uspto.gov/patents/resources/terms/156.jsp.
3. Wikipedia. The free Encyclopedia. List of best selling drugs. USA, 2010. Fecha de consulta: 7 de marzo de 2011. Disponible en: http://en.wikipedia.org/wiki/List_of_bestselling_drugs.
4. Redford H. The same but different. Nature. 2007;449:274-6.
5. Schellekens H. When biotech proteins go off-patent. Trends Biotechnol. 2004:22:406-10.
6. Calvo B, Zúñiga L. Medicamentos biotecnológicos: requisitos exigidos para el desarrollo y aprobación de biosimilares. Información Tecnológica. 2010;21:125-32.
7. Amgen Inc. Recombinant DNA technology. Canada, 2011. Fecha de consulta: 7 de marzo de 2011. Disponible en: en:http://www.amgen.ca/english/science/about_biotechnology_recombinant_dna_technology.html.
8. Schellekens H. Biosimilar therapeutics –What do we need to consider? NDT Plus. 2009;2:i27-36.
9. Roger SD. Biosimilars: How similar or dissimilar they are. Nephrology. 2006;11:341-6.
10. Karpusas M, Whitty A, Runkel L, Hochman P. The structure of human interferon-beta: Implications for activity. Cell Mol Life Sci. 1998;54:1203-16.
11. Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res. 2007;30:267-72.
12. Schellkens H. Follow-on biologics: Challenges of the “next” generation. Nephrol Dial Transplant. 2005;20:iv31-6.
13. EMEA/H/C/000585. Refusal assessment report for Alpheon E. London, UK. 2006. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000585/WC500070792.pdf.
14. Lazcano-Ponce E, Salazar-Martínez E, Gutiérrez-Castrellón P, Ángeles-Llerenas A, Hernández-Garduño, Viramontes JL. Ensayos clínicos aleatorizados: variantes, métodos de aleatorización, análisis, consideraciones éticas y regulación. Salud Pública de México. 2004;46: 559-84.
15. Friedman LM, Furberg CD, De Mets DL. Fundamentals of clinical trials. Fourth edition. New York, USA: Springer; 2010.
16. EMEA/CHMP/437/04. Guideline on similar biological medicinal products. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.emea.europa.eu/(2005).
17. EMEA/CHMP/BWP/49348/05. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues (CHMP adopted February 2006). Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.emea.europa.eu/(2006).
18. EMEA/CHMP/42832/05. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non clinical and clinical issues (CHMP adopted February 2006). Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.emea.europa.eu/(2006).
19. Wiecek A, Mikhail A. European regulatory guidelines for biosimilars. Nephrol Dial Transplant. 2006;21:v17-20.
20. EMEA/CHMP/94528/05. Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non clinical and clinical issues –Guidances on similar medicinal products containing Somatropin (CHMP adopted February 2006). Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.emea.europa.eu/(2006).
21. EMEA/CHMP/94526/05. Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Non clinical and clinical issues –Guidances on similar medicinal products containing recombinant erythropoietins (CHMP adopted March 2006). Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.emea.europa.eu/(2006).
22. EMEA/CHMP/31329/05. Annex guideline on similar biological medicinal products containing biotechnologyderived proteins as active substances: Non clinical and clinical issues –Guidances on similar medicinal products containing recombinant granulocyte-colony stimulating factor (CHMP adopted February 2006). Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.emea.europa.eu/(2006).
23. ORDEN SCO/2874/2007 de 28 septiembre, por la que se establecen los medicamentos que constituyen excepción a la posible sustitución por el farmacéutico con arreglo al artículo 86.4 de la Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios (BOE núm. 239, de 5 octubre [RCL 2007, 1818]) Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.aemps.es/actividad/legislacion/espana/docs/rcl_2007_1818-2009-1.pdf.
24. Chu R, Pugatch M. Biogenerics or biosimilars: Discussing the present, considering the future. Stockholm, 2009. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.stockholm-network.org/downloads/publications/Biosimilars_FINAL.pdf.
25. Patent Docs. Clinical Trials are top issue at FDA hearings on biosimilars. USA, 2010. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.patentdocs.org/2010/11/clinical-trial-requirements-are-top-issue-at-fda-hearings-onbiosimilars.html.
26. Caicedo L. Biosimilares: otro reto de la medicina del futuro. Bogotá, Colombia, 2007. Fecha de consulta: 4 de marzo de 2011. Disponible en: http://www.biofarmacos.org/files/contenido/Biosimilares%20otro%20reto%20de%20la%20medicina%20del%20futuro.pdf.
27. Colprensa. Colombia avanza en la reglamentación de medicamentos biotecnológicos. Cartagena, Colombia 2011. Fecha de consulta: 4 de abril de 2011. Disponible en: http://www.eluniversal.com.co/cartagena/vida-sana/colombia-avanza-enla-reglamentacion-de-medicamentos-biotecnologicos-18642.
How to Cite
1.
Sanclemente G. What dermatologists should know about biologics and biosimilars. rev. asoc. colomb. dermatol. cir. dematol. [Internet]. 2019 Mar. 4 [cited 2024 Jul. 3];19(4):321-9. Available from: https://revista.asocolderma.org.co/index.php/asocolderma/article/view/353
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2019-03-04
How to Cite
1.
Sanclemente G. What dermatologists should know about biologics and biosimilars. rev. asoc. colomb. dermatol. cir. dematol. [Internet]. 2019 Mar. 4 [cited 2024 Jul. 3];19(4):321-9. Available from: https://revista.asocolderma.org.co/index.php/asocolderma/article/view/353
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