HOT TOPIC : ESMO POSITION PAPER
ESMO is the European Society for Medical Oncology. A position paper by Tabernero J et al has been published in the ESMO Open BMJ journal seeking to inform prescribers in medical oncology on biosimilars and the expanded treatment options they provide. The paper discusses how biosimilars can change the medical oncology field by providing more treatment options to physicians and patients as well as increasing the access of patients to life-saving medicines.
Since their introduction, biologics, of which biosimilars are a subset, have brought new therapeutic options to patients across a large number of disease areas. Whereas the first biosimilars were simple proteins such as insulin, second generation biosimilars are far more complex monoclonal antibodies that are used in the treatment scheme of life threatening diseases such as cancer. With the looming patent expiry of the majority of monoclonal antibody biologics by 2020, the introduction of biosimilars in the formulary offers physicians and patients a greater number of treatment choices. When developed and manufactured to the correct standards, biosimilars can help tackle the issue of healthcare system sustainability and increasing access of patients to life-saving medicines.
To ensure that all patients are prescribed the safest and most efficacious treatment possible, physicians need to understand what makes biosimilars effective treatment options and how these are different from other therapies and each other. Recreating a product made by living organisms introduces small changes that do not affect the biological activity of the product but at the same time the product is not identical to the originator nor to other biosimilars made by different manufacturers. Treating patients with a biosimilar should be no different than treatment with the originator in terms of medical benefit. Inclusion of biosimilars as treatment options should be based on an understanding of the label, how the indication is extrapolated, recommended practices for switching and totality of evidence.
LABELING OF BIOSIMILARS:
The labelling of biosimilars provides physicians and patients with the necessary information on the product and its effects and should include information from the clinical studies. According to guidelines from the EMA, FDA and WHO, the label must also reflect the brand name of the originator biologic instead of the international non-proprietary name in order to properly track any adverse events. Thus the summary of product characteristics should reflect the information on the product and refer to appropriate sections of the EPAR (European Public Assessment Report).
EXTRAPOLATION OF INDICATIONS:
should be permitted if verified scientifically based on the robustness and totality of evidence.
INTERCHANGEABILITY, SWITCHING AND AUTOMATIC SUBSTITUTION:
Physicians should be aware if and when a product is switched. The decision to switch should be taken exclusively by the physician, with the informed consent of the patient who is monitored for any adverse events. Automatic substitution should be avoided for biosimilars. Interchangeability and switching should be permitted if: 1. the physician is well informed about the product, 2. the patient is fully briefed, and 3. a nurse monitors changes and records any adverse events.
Marketing approval of biosimilars should include bioequivalence and bioavailability data as well as pharmaceutical, chemical and biological findings. Given the complexity of biosimilars, ensuring their safety and efficacy is critical. EMA provides robust guidelines for non-clinical and clinical study design. Once a biosimilar is on the market, pharmacovigilance and Phase IV studies are essential to ensure efficacy and safety of prolonged exposure.
In conclusion, the oncologist, like all physicians, needs to make a decision on what is best for their patients. When it comes to prescribing, it is crucial that enough clinical data is available in order to instil confidence in prescribers, patients and pharmacists concerning biosimilars. Biosimilars are ultimately prescribed to help the patients and their optimal safety and efficacy is the shared responsibility of manufacturer and regulatory bodies.
- Tabernero J et al. ESMOOpen 2016;1:e000142