Article Text

Download PDFPDF

Considering biosimilar policy
  1. Gilberto Castañeda-Hernández1,
  2. Robert Strohal2,
  3. João Gonçalves3,
  4. Thomas Dörner4,
  5. Valderilio Azevedo5,
  6. John Isaacs6,
  7. Iain McInnes7
  1. 1 Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional, Mexico City, Mexico
  2. 2 Federal University Teaching Hospital Feldkirch, Feldkirch, Austria
  3. 3 University of Lisbon, Lisbon, Portugal
  4. 4 Charité Universitätsmedizin Berlin, Berlin, Germany
  5. 5 Federal University of Paraná, Paraná, Brazil
  6. 6 Newcastle University, Newcastle upon Tyne, UK
  7. 7 University of Glasgow, Glasgow, UK
  1. Correspondence to Gilberto Castañeda-Hernández, Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Naciona, Mexico City, Mexico, castanedagil{at}


With the authorisation of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Current naming policies are not universal; neither are extrapolation criteria. Indeed, consideration of whether we can extrapolate information from one indication or disease to another continues to be a divisive topic. However, this is changing, as we strive for a more harmonised approach.

Such a unified approach will be needed when considering future strategies to follow for multiple biosimilar switching, especially so because there is currently no uniform policy regarding interchangeability, switching, and automatic substitution. In this multiple biosimilar setting, the question as to whether we can be confident to move across indications will be increasingly important. The cost of biosimilar switching also needs to be considered—biosimilar use may mean that patients need more training and medical visits, with associated administrative costs.

The biosimilars debate seems to be refocusing issues that have previously been extensively discussed but that have recently lost impetus, including the role of clinical pharmacology in internal medicine.

View Full Text

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.