British oncologists back biosimilar mAbs to treat cancer

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British oncologists back biosimilar mAbs to treat cancer

INICIO/Políticas y legislación | Posted 03/03/2017 0 Post your comment

The British Oncology Pharmacy Association (BOPA) announced on 7 February 2017 the publication of its position statement and implementation guidelines on Biosimilar Monoclonal Antibodies.

In its guideline document BOPA states that ‘oncology pharmacy teams are key to ensuring the safe, successful and timely adoption of biosimilar monoclonal antibodies (mAbs)’.

BOPA’s position is that ‘biosimilar mAbs are therapeutically equivalent to the originator molecules and can and should be used for all commissioned indications, provided pharmacovigilance safeguards are in place, e.g. branded prescribing.

Although BOPA acknowledges that ‘biosimilar mAbs cannot be automatically substituted’ they state that ‘switching from originator to biosimilar (or biosimilar to biosimilar) is acceptable and can be recommended as part of a medicines optimisation strategy’. They also believe that ‘oncology pharmacy teams have a key role in helping clinicians initiate or switch patients to biosimilar mAbs, either by directly supporting clinicians when seeing patients in clinic or indirectly by counselling patients in pharmacy, on wards or chemotherapy day units’.

The group adds that ‘oncology pharmacy teams are key to ensuring pharmacovigilance monitoring is in place to ensuring all biosimilars are prescribed by brand and batch numbers are tracked’. They add that ‘all patients switched from originator to biosimilar, or between biosimilars should be monitored and that the biosimilars SmPC (Summary of Product Characteristics) guidance on administration rates should be followed’. This they say ‘will ensure that the evidence base for safe switching is increased.’

BOPA also believes that ‘biological medicines in general are safe and well tolerated, with the potential for immunogenicity the main safety concern and that adverse reactions are likely to be batch related and not product related’.

In addition, the group states that ‘BOPA believes that the savings achieved by rapid adoption of biosimilar mAbs are an opportunity to safeguard NHS (National Health Service) budgets’ and ‘ensure that new innovative cancer medicines are affordable’. This they say will benefit patients and clinicians as well as significantly reduce NHS expenditure.

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Source: BOPA