In response to the recent bioboom, physicians may consider switching patients to a biosimilar for a more affordable alternative. However, this is a decision that shouldn’t be made in haste and has a few crucial points to be considered.
In a study conducted between late 2015 and January 2016, 91% of physicians were found to be willing to prescribe biosimilars, but only 45% agreed that such products would be appropriate and safe for their patients’ use.
Data from incrowd has shown that more doctors say yes to biosimilars with 84% anticipating that they will prescribe biosimilars in next 3 years, up by 14% from 6 months prior.
Despite this, the level of caution has increased with those accepting pharmacy-level substitutions dropping from 28% to 17%.
More elements are being considered in a physician’s choice to prescribe biosimilars at all.
Among the top 10 most important factors in choosing to prescribe a biosimilar, physicians are placing greater emphasis on thought leader opinions and professional organization guidelines as well as patient acceptance of biosimilars.
In switching stable patients or those only recently diagnosed to biosimilars, there are some crucial considerations to avoid degradation in the quality of disease treatment.
The intricate nature of biomolecules means that switching a patient from a biologic to a biosimilar should be decided on a case by case basis. The level of risk should be compared to the level of evidence for success.
These details should be scrutinised by both physician and patient.
The European Trade Association for biopharmaceutical companies (EBE), European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) provided guidance on the key aspects that should frame the decision making process when contemplating a switch to biosimilars.
On its website, the IFMPA said: “Biosimilars have an important role to play in promoting the sustainability of healthcare systems. Used appropriately, biosimilars will provide health systems with the financial headroom to maintain investment in new technologies and therapies.”
1. Compare all the biosimilars associated with the biologic
In order to achieve approval a biosimilar is compared to its branded equivalent on number of categories: quality safety and efficacy. One reference product may have multiple biosimilars approved in the market.
Switching between biosimilars is an unknown according to the paper and full of uncertainties due to the lack of relevant clinical data.
The IFPMA notes that when applying for marketing authorisation there is no stipulation to compare the biosimilar to any other approved biosimilars for the same reference product. So, it is unlikely that this data will be available to physicians considering a switch between two biosimilars.
2. Refer to regulatory submissions
When considering a switch from a reference product to a biosimilar, regulatory submissions could have useful data to inform a decision. The level of data is expected to vary according to the submission at hand
3. Were global guidelines followed in approval of the biosimilar?
“In some parts of the world so-called “noncomparable biotherapeutic products”are available – those that have not been directly compared with the reference product and therefore may not meet global standards.” according to the paper. An obvious risk to patient safety is present in these cases.
4. Consider the nature of the product
The nature of a biologic’s immunogenicity can cause a variety of outcomes. The paper notes that naturally occurring hormones/cytokines/receptors can present an increased risk of serious consequences.
5 How is the dose administered?
A change in dosing device for a biosimilar could increase the uncertainty in patient adherence due to unfamiliarity in taking the medicine. The authors highlight that subcutaneous administration is more immunogenic than intravenous administration.
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It is not advised to switch to a biosimilar if the current treatment of choice has lost effectiveness for the patient or tolerability issues have started to arise. This is because the biosimilar is expected to have a similar clinical efficacy to the original biologic. So the potential benefit to the patient would be minimal if any.
Also if the switch could limit future treatment options for the patient then physicians must question whether the change is in fact a positive move.
In deciding to switch to a biosimilar, apt pharmacovigilance measures should be deployed. The patient should be informed promptly at all times on their clinical progress.