One-Size-Fits-All Approach "Not Appropriate" for Biosimilar Switching Decisions

March 9, 2017

March 09, 2017

  European Biopharmaceutical Enterprises (EBE), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the IFPMA have today launched a position paper on “Considerations for physicians on switching decisions regarding biosimilars”.   In a press release, the associations write that with the introduction of biosimilars, physicians may be encouraged to switch patients from an original biologic (reference product) to any of its biosimilars (or vice versa) in order to reduce costs.   The considerations take into account the unique characteristics of biologic medicines, which are capable of treating patients with highly complex diseases – and caution that switching stable patients is still nascent in practice. The three associations underscore the central role of the physician – together with the patient – in the decision-­making process when it comes to providing the appropriate treatment for both naïve and disease-stable patients.   This means that:

  • The prescribing physician must always retain the option to designate which biological product should be dispensed. Treatment decisions must be made first on the basis of clinical judgment and then on the overall value proposition offered by individual medicines.

  • The treating physician, in consultation with the patient, should make any decision to switch patients from one biological product to another. Where switching occurs, it must be accompanied by adequate clinical monitoring and the patient must be informed appropriately at all times.

All biologics approved by regulatory authorities (e.g. the European Medicines Agency) in compliance with relevant WHO guidelines are safe, effective and of high quality. Moreover, a biosimilar must be compared in terms of quality, safety and efficacy with its reference product before it qualifies for approval. However, there is no regulatory requirement for individually approved biosimilars for the same reference product to be compared with each other. Consequently, this type of data may not be available to stakeholders when evaluating a switch between two biosimilars of the same reference product.   The complex nature of biological molecules, which are often used to treat patients who have multifaceted, chronic diseases, means that any decision to switch should be made on a case-by-case basis and must be patient-­, disease-­ and product-specific. It is vital for a physician to balance the level of evidence against the level of risk or uncertainty in each particular case. A ‘one size fits all’ approach is not appropriate, the associations say.  

The position paper can be accessed here.