Evaluación de la biosimilitud y comparabilidad de medicamentos biosimilares

  1. Calvo Hernáez, Begoña 1
  2. Zúñiga Hernando, Leyre 1
  3. Gómez López Tello, Paloma 1
  1. 1 Universidad del País Vasco, España
Journal:
Ars pharmaceutica

ISSN: 2340-9894,  0004-2927

Year of publication: 2013

Volume: 54

Issue: 4

Pages: 32-36

Type: Article

DIALNET GOOGLE SCHOLAR lock_openOpen access editor

More publications in: Ars pharmaceutica

Abstract

Some biotechnology-derived medicines (e.g. therapeutic proteins and monoclonal antibodies) patents have expired allowing the so-called biosimilars hit the market. As biosimilars are similar but not identical to the innovator product the existing legal framework for generic drugs does not apply. The applicant of a biosimilar marketing authorization must demonstrate that its product is as safe and effective as the innovator product (reference product). This comparison is performed by means of a “biosimilarity /comparability exercise”, which includes analytical characterization of both products (innovator and biosimilar), stability studies and preclinical and clinical studies to determine the pharmacokinetics, pharmacodynamic and immunogenic evaluation of the biosimilar medicine. Efficacy and safety studies are also required.

Bibliographic References

  • Zúñiga L, Calvo B. Biosimilars approval process. Regul Toxicol Pharmacol. 2010; 56:374-7.
  • Weise M, Bielsky MC, De Smet K, Ehmann F, Ekman N, Giezen TJ, et al. Biosimilars: what clinicians should know. Blood. 2012; 120:5111-7.
  • European Medicines Agency. Guideline on similar biological medicinal product, EMA (CHMP/437/04). 2004 [citado 15 enero 2013]. Disponible en: http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf
  • European Medicines Agency. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1), EMA (CHMP/BWP/247713/2012). 2012 [citado 15 enero 2013]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/05/WC500127960.pdf
  • European Medicines Agency. Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues, EMA (CPMP/3097/02). 2003 [citado 15 enero 2013]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003963.pdf
  • European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance. Quality issues, EMA (CHMP/BWP/49348/05). 2006 [citado 15 enero 2013]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003953.pdf
  • European Medicines Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance. non-clinical and clinical issues, EMA (CHMP/BMWP/42832/05). 2006 [citado 15 enero 2013]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003920.pdf
  • European Medicines Agency. Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology derived proteins as active substance: non-clinical and clinical issues, EMA (CHMP/BMWP/572828/2011). 2011 [citado 15 enero 2013]. Disponible en: http://www.ema.europa.eu/docs/
  • en_GB/document_library/Scientific_guideline/2011/10/WC500115611.pdf
  • European Medicines Agency. Annex to guideline on similar biological medicinal products containing biotechnologyderived proteins as active substance: non-clinical and clinical issues - Guidance on biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor, EMEA (CHMP/BMWP/31329/2005). 2006 [citado 15 enero2013]. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003955.pdf
  • European Medicines Agency. Guideline on similar biological
  • medicinal products containing monoclonal antibodies – nonclinical
  • and clinical issues, EMA (CHMP/BMWP/403543/2010). 2012 [citado 15 enero 2013]. Disponible en: http://www.ema.europa.eu/docs/
  • en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
Data source: Dialnet