The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance for prescribers on switching between originator biologicals and biosimilars.
The position paper entitled ‘Considerations for physicians on switching decisions regarding biosimilars’ outline considerations that the groups believe should be taken into account when a physician decides to exchange an originator biological (reference product) to any of its biosimilars (or vice versa).
The three associations highlight the central role of the physician and patient. They recommend that the prescribing physician must retain the right to designate which biological should be dispensed on the basis of clinical judgement. They add that any decision to switch must also be made by the physician, in consultation with the patient. In addition, where switching occurs, it must be accompanied by adequate clinical monitoring and the patient must be informed appropriately at all times.
The position paper, which was issued on 9 March 2017, contains a table that outlines the key factors and considerations for prescribers when considering a switch. It also highlights two scenarios where switching is NOT recommended:
- when the initial treatment choice, e.g. reference product or biosimilar, loses efficacy or when there are tolerability issues.
- if the physician feels that on balance a switch is likely to compromise future treatment options for the patient, e.g. with an alternate biological therapy.
The associations conclude that the ‘physician is best placed to assess the patient, disease and product, when deciding if and how to switch the biological product that a patient is receiving for another one’. They add that ‘effective pharmacovigilance (PV) for biologic[al]s is always important, especially when there are multiple treatment options available’. In addition, they state that ‘to achieve this, measures to identify the product by brand name and batch number are needed in policy and in practice’. Finally, they caution that ‘the effectiveness of the PV system, as well as on safety reporting practices amongst not only Regulatory Authorities and manufacturers, but also healthcare providers, patients and the wider public’.
The European Crohn’s and Colitis Organisation (ECCO) recently recommended that ‘switching from the originator to a biosimilar in patients with inflammatory bowel disease (IBD) is acceptable’. Similarly, they also recommended that ‘switching from originator to a biosimilar should be performed following appropriate discussion between physicians, nurses, pharmacists, and patients’ [1]. While results of the NOR-SWITCH study have shown similar safety and efficacy in patients switched from the originator biological Remicade to the infliximab biosimilar (Remsima, CT‑P13) [2].
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References
1. GaBI Online - Generics and Biosimilars Initiative. European IBD specialists support switching to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/General/European-IBD-specialists-support-switching-to-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 17]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
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