Biosimilars Present an Opportunity for Oncology Patients, Prescribers, and Health Systems

Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer. As a recent position paper by the European Society for Medical Oncology (ESMO) points out, the anticancer market is expected to pass the €140 billion (apx. $157 billion) by 2020, forcing nations around the world to confront the challenge of healthcare-system sustainability and patient access to these important medications. “Biological and medicinal products, or those whose active substance is made by a living organism, will represent 19% [to] 20% of the total global share of pharmaceutical sales by 2017, and thus form an essential part of the anticancer medicines offering,” ESMO explains.

Biosimilars, typically marketed at discounts relative to originator drugs, present a necessary opportunity for patients, physicians, and healthcare systems to positively impact the financial sustainability of global health systems when they are developed in clinically suitable ways, manufactured to correct standards, and used appropriately. Biosimilar clinical development must be recognized as an opportunity for healthcare in light of potential savings in a future where these drugs could compete with originator drugs, as noted by Emilio Bria (University of Verona) and Pierfranco Conte (University of Padua and Instituto Oncologico Veneto) in an accompanying editorial.

As the majority of monoclonal antibodies are due to reach patent expiry by 2020, the oncology landscape faces changes, ESMO notes. To ensure that patients are being prescribed the safest, most effective treatments possible, all key players must understand the complexities of biosimilars and make decisions in patients’ best interests. In addition, it is important to increase confidence in biosimilars among prescribers and patients so that continued adoption and uptake of biosimilars results in greater patient access to important biologic treatments.

The position paper, published in January 2017 in ESMO Open, describes issues concerning biosimilars that are particularly relevant to the oncology field:

• Labeling is of crucial importance, as biosimilars are not identical copies of originator drugs but are the best possible versions of reference products. Thus, labels must provide necessary information for patients and physicians about the products and their effects, including clinical study data and details of pharmacovigilance plans. Labels should reflect the brand names of originator, ESMO states, in order to properly track related adverse events.

• Extrapolation—extending information and conclusions from studies in one or more groups of patients to make inferences for another subgroup of populations—should be permitted if verified scientifically. ESMO states that extrapolation may be acceptable in the EU and globally if there are enough relevant data, including data on immunogenicity. There must also be, ESMO states, justifications of any differences among data.

• Interchangeability and switching are critical issues in oncology, and there is no consensus in the EU concerning these practices. ESMO cautions that any decision to switch or substitute biosimilars requires a deep understanding of the product by physician prescribers. Full information for and close monitoring of patients is crucial. Automatic substitution should be avoided with biosimilars, ESMO states.

• Enforcement of clinical standards for safety and efficacy is imperative. Safety, efficacy, and immunogenicity data should be tested in the most sensitive populations with clearly reported of data. This testing will build confidence in physician and patient alike.

• ESMO states that prescribers have a duty to select medications matched to specificities of their patients. Both prescribers and pharmacists have a duty to educate patients fully so that they are informed and can understand and participate in decisions about the use of biosimilars. Pharmacists should not be allowed to automatically switch the biosimilar without the knowledge and consent of prescribers and patients.

The introduction of biosimilars is expected to have a cumulative potential savings of €50 billion to €100 billion by 2020. ESMO recommends monitoring the potential impacts of biosimilars on financial burdens in health care, keeping in mind that the potential savings has a direct correlation with the successful uptake of biosimilars. “Globally, the next 5 years will be important for biosimilars, for their uptake and their impact on healthcare systems,” the paper concludes.