Acta Scientific Pharmacology

Review Article Volume 1 Issue 7

Biosimilars: An European Overview

Anna Ponzianelli, Nicolo’ Bendinelli*, Cristina Vilei, Annalaura Giorgio, Roberta Laurita, Diletta Schito, Umberto Finelli, Nicoletta Martone, Viviana Ruggeri, Valeria Viola and Enrico Bosone

SIARV, Società Italiana Attività Regolatorie, Accesso, Farmacovigilanza, Via della Rocchetta, Pavia, Italy

*Corresponding Author: Nicolo’ Bendinelli, SIARV Società Italiana Attività Regolatorie, Accesso e Farmacovigilanza, Via Antonio Salandra, Rome, Italy.

Received: May 28, 2020; Published: June 11, 2020

×

Abstract

Biosimilar drugs represent the possibility to improve patient access to medicines but also alleviate financial burden faced by stakeholders in the currently constrained European budgetary environment. We reviewed key drivers and policies of biosimilar uptake in Europe, underlying national authorization pathways, timing and strategies. National healthcare systems features as well as physicians prescribing culture, have been featured resulting in a deep heterogeneity and in various policies referable to three main areas: pricing, reimbursement and demand. Unlike Italy and UK, where incentives for prescribers are planned at regional level, France and Germany extended them nationally. There are now substantial evidences of a common reduced familiarity with biosimilar drugs in countries where substitution is not allowed. To date, Germany, Spain, Portugal, Sweden, Norway, Finland, Austria, Holland, Czech Republic, Hungary and Romania introduced rules to avoid or limit automatic substitution by the pharmacy without physician consent. We evaluated where and why awareness-rising initiatives could be more adequate if tailored on physicians rather than on poorly informed patients. Furthermore, being an extensively mentioned issue within scientific community, we focused on biosimilar pre and post marketing risk/benefit profile assessment. No Regulatory Agencies requires clinical studies to confirm the originator maintained pharmacological characteristics over time or after major variations in productive process. Based on November 2019 European Commission ‘Health and Food Safety Directorate working Group’ discussion, a final commentary on the predictable increment of biosimilar duplicate marketing authorizations is given.

Keywords: Biosimilar; Access; Sustainability; Pricing; Market Penetration; Policy

×

References

  1. Simon-Kucher. “Partners Payers’ P and MA policies supporting a sustainable biosimilar market, Report”. Medicines for Europe (2016).
  2. Foxon G., et al. “Are EU payers adapting biosimilar pricing and reimbursement approval processes to optimize healthcare savings?” ISPOR 20th Annual International Meeting (2015): 16-20.
  3. National Institute for Health and Care Excellence, Biosimilar medicines (2020).
  4. Italian Official Gazette, 21 June 2006 - Ordinary Supplement (2020): 153.
  5. Agenzia Italiana del Farmaco, Autorizzazione dei farmaci (2019).
  6. Spanish Art. 93.7 Law 29/2006 for the guarantee and rational use of medicines and medical devices (2020).
  7. Les medicaments biosimilaires en France: Quelles perspectives de croissance a l’horizon (2020).
  8. Cécile Rémuzat., et al. “Key drivers for market penetration of biosimilars in Europe”. Journal of Market Access and Health Policy 5 (2017): 1.
  9. Advancing Biosimilar Sustainability in Europe - IQVIA Institute Report (2018).
  10. Begona Calvo., et al. “The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation”. Therapeutic Advance in Drug Safety10 (2018): 601-608.
  11. European Medicines Agency. Biosimilars in the EU - Information guide for healthcare professionals (2020).
  12. Agenzia Italiana del Farmaco - Position Paper sui Farmaci Biosimilari (2019).
  13. GaBi Online, Biosimilar substitution in Europe (2020).
  14. GaBI Online, Finnish drug regulator recommends interchangeability of biosimilars (2020).
  15. Interchangeability of biosimilars, Position of Finnish Medicines Agency Fimea (2020).
  16. GaBI Online, Generics and Biosimilars Initiative. Saving money and building trust in biosimilars (2020).
  17. Agenzia Italiana del Farmaco - Secondo Position Paper sui Farmaci Biosimilari (2019).
  18. Gabi Online, A strategic approach to increase uptake of biosimilars in Spai (2020).
  19. GaBi Online, Challenges for biosimilar sustainability in Europe (2020).
  20. Allocati E., et al. “Clinical evidence supporting the marketing authorization of biosimilars in Europe”. European Journal of Clinical Pharmacology 4 (2020): 557-566.
  21. Frapaise FX. “The end of phase 3 clinical trials in Biosimilars development?” Bio Drugs4 (2018): 319-324.
  22. Bio Farmind, Biopharmaceuticals and biosimilars (2020).
  23. Marcellusi A., et al. “Impatto economico dei biosimilari degli anti-TNF in Italia: una analisi di scenario”. Gihtad 12 (2019): 6.
  24. Ingrasciotta Y., et al. “Safety of Biologics, Including Biosimilars: Perspectives on Current Status and Future Direction”. Drug Safety 41 (2018): 1013-1022.
  25. Specialist Pharmacy Services, NHS England (2020).
  26. Pharmaceutical Committee, Duplicate marketing authorisations for biological medicinal products. European Commission (2019).
×

Citation

Citation: Nicolo’ Bendinelli., et al. “Biosimilars: An European Overview".Acta Scientific Pharmacology 1.7 (2020): 06-13.




Metrics

Acceptance rate36%
Acceptance to publication20-30 days

Indexed In


News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is December 25, 2024.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of "Best Article of the Issue"

Contact US