PT  - JOURNAL ARTICLE
AU  - Gilberto Castañeda-Hernández
AU  - Robert Strohal
AU  - João Gonçalves
AU  - Thomas Dörner
AU  - Valderilio Azevedo
AU  - John Isaacs
AU  - Iain McInnes
TI  - Considering biosimilar policy
AID  - 10.1136/conmed-2017-100006
DP  - 2017 Nov 01
TA  - Considerations in Medicine
PG  - 19--24
VI  - 1
IP  - 1
4099  - http://considerations.bmj.com/content/1/1/19.short
4100  - http://considerations.bmj.com/content/1/1/19.full
SO  - Considerations Med2017 Nov 01; 1
AB  - 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.