Clinical judgement first, value proposition second: drugmakers issue joint global position paper on biosimilar switching

European and global drug bodies have joined forces to send a strong message: when it comes to decisions around biosimilar switching, clinicians and patients must come first.  In a joint statement released this week, three industry trade bodies came together to stress that physicians and patients must be central to the decision-making process. They added that any decision to switch must be made on a case-by-case basis, and that a “one-size-fits-all” approach is not appropriate.

The position paper, released by the European Biopharmaceutical Enterprises (EBE), European Federation of Pharmaceutical Industries and Associations (EFPIA), and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the organisations highlight the role biosimilar medicines can play in contributing to the sustainability of healthcare systems, while emphasising the conditions under which a switch can safely take place. The position update from these organisations follows the publication of the NOR-SWITCH study in October last year, which has increased the level of attention paid to biosimilar medicines and safe switching among physicians, policymakers and patients across the globe. GAfPA’s white paper on NOR-SWITCH provides further information on the study and its limitations in terms of what it can tell the healthcare community about switching.

GAfPA welcomes EBE, EFPIA and IFPMA’s position paper, which seeks to inform physicians which factors which should be taken into account when considering whether to switch a patient to a biosimilar medicine. Of particular note, the paper recommends that treatment decisions must be ‘made first on the basis of clinical judgement and then on the overall value proposition’ and that “the treating physician, in consultation with the patient, should make any decision to switch patients from one biological product to another”.

The position paper also says that “when switching does occur, it must be accompanied by adequate clinical monitoring and the patient must be informed appropriately at all times”.

There are also two conditions outlined under which the organizations recommend a switch should not take place, both of which have a clinical focus, with the importance of patient outcomes at their core:

  • ‘When the initial treatment choice e.g. reference product or biosimilar loses efficacy, or when there are tolerability issues, switching to a similar product within the same group of related products is not recommended’
  • ‘If the physician feels that on balance a switch is likely to compromise future treatment options for the patient’

Meanwhile, when it comes to multiple switching between biosimilars, the position is very clear. The industry bodies warn that “switching between biosimilars represents an unknown, and one that harbours considerable uncertainty.”

In patient advocacy workshops held across Europe, including in the European Parliament, GAfPA has heard that patients want to be involved in key decisions about their care. GAfPA has also heard from physicians that sometimes they have no choice in the discussion about what to prescribe their patient. It is therefore highly significant that the position paper emphasises the relationship between an informed physician and their patient, and that the decision to switch a patient should always rest with the prescribing physician.

In addition, GAfPA also welcomes the emphasis placed on adequate clinical monitoring once a switch occurs. At present, there are no peer-reviewed studies which examine the long-term impact of switching and multiple switching (switching between biosimilar products), so it is vitally important that any side effects or worsening of a condition as a result of a switch are appropriately tracked and recorded. GAfPA is helping to educate patients on how to report side effects accurately to regulators, and get involved in supporting national-level and European pharmacovigilance systems.

Overall, the position paper provides much needed clarity from industry bodies around the importance of physician decision making on switching patients to biosimilars, in which clinical judgement and patient information is prioritized. GAfPA therefore welcomes the paper, and looks forward to discussing it at our events taking place across Europe in 2017.