Patient & Prescriber views on switching from a biologic to biosimilar

  • Research type

    Research Study

  • Full title

    Development of a process from switching from a biologic to a biosimilar which is acceptable to both patients and prescribers.

  • IRAS ID

    199526

  • Contact name

    Denise Rosembert

  • Contact email

    denise.rosembert@addenbrookes.nhs.uk

  • Sponsor organisation

    University of East Anglia

  • Clinicaltrials.gov Identifier

    V1 31/03/16, Development of an acceptable patient pathway to enable switching from a Biologic to a Biosimilar, for both patients and prescribers.

  • Duration of Study in the UK

    0 years, 4 months, 26 days

  • Research summary

    The process of research, discovery and manufacture of a biological medicine is expensive; this contributes to the high contract prices which NHS hospitals pay to use these therapies. In 2014/2015, the annual spend on biologics at Cambridge University Hospital was approximately £7.5 million, accounting for 10% of the Trusts overall drugs budget. The proportion of expenditure on biologics in the United Kingdom is reported to be 23% of all medication.

    The expiration of patents of these medications means that more pharmaceutical companies can begin to make a similar medication and sell at a more competitive price. These conditions are serious and chronic, and unlike generic medicines, these medicines are made from living biological cells, so cannot be exact copies. Recommendations include not to automatically switch patients with out discussion with the prescriber and patients, the reason for this research is to conduct two patient focus groups to understand how to approach this processes to ensure an effective and informed process for switching patients. The outcomes from this will be presented to the consultants and inform the process of going about the switch.

  • REC name

    East of England - Essex Research Ethics Committee

  • REC reference

    16/EE/0212

  • Date of REC Opinion

    31 May 2016

  • REC opinion

    Further Information Favourable Opinion