The use of biosimilar medicines in oncology - position statement of the Brazilian Society of Clinical Oncology (SBOC)

Abstract

A biosimilar is a biologic product that is similar to a reference biopharmaceutical product, the manufacturing process of which hinders the ability to identically replicate the structure of the original product, and therefore, it cannot be described as an absolute equivalent of the original medication. The currently available technology does not allow for an accurate copy of complex molecules, but it does allow the replication of similar molecules with the same activity. As biosimilars are about to be introduced in oncology practice, these must be evaluated through evidence-based medicine. This manuscript is a position paper, where the Brazilian Society of Clinical Oncology (SBOC) aims to describe pertinent issues regarding the approval and use of biosimilars in oncology. As a working group on behalf of SBOC, we discuss aspects related to definition, labeling/nomenclature, extrapolation, interchangeability, switching, automatic substitution, clinical standards on safety and efficacy, and the potential impact on financial burden in healthcare. We take a stand in favor of the introduction of biosimilars, as they offer a viable, safe, and cost-effective alternative to the biopharmaceutical products currently used in cancer. We hope this document can provide valuable information to support therapeutic decisions that maximize the clinical benefit for the thousands of cancer patients in Brazil and can contribute to expedite the introduction of this new drug class in clinical practice. We expect the conveyed information to serve as a basis for further discussion in Latin America, this being the first position paper issued by a Latin American Oncology Society.

Barriers towards effective pharmacovigilance systems of biosimilars in rheumatology: A Latin American survey

“…The assessment of similarity involves iterative structural and functional characterisation and, if needed, in vivo non‐clinical evaluation and clinical studies, all comparing the potential biosimilar with its reference product . However, there are disparities across the world in the regulatory approval pathways for biosimilars, and on the interchangeability of reference products and biosimilars at the prescriber or the pharmacy level …”

Biosimilars in oncology and inflammatory diseases: current and future considerations for clinicians in Latin America

“…Indeed, a 2018 position statement on biosimilars from the Brazilian Society of Clinical Oncology emphasizes that decisions regarding extrapolation “should be made on a case-by-case basis,” rather than automatically. 145 Thus far, the concept of extrapolation has been validated by the post-authorization clinical experience with approved biosimilars in regions such as the EU. 62 …”

“…28 As such, a cultural shift may be required in the medical community towards giving greater importance to reporting AEs. 145 …”

“…84 Indeed, Brazilian medical societies have expressed their support for a distinctive nomenclature system for biosimilars and originator products. 144,145 One suggestion has been to use the manufacturer’s name as a unique identifier. 84 As biosimilar guidelines in Latin America do not consider the naming of these agents, 46 this remains an area for clarification.…”

“…153 As a result, switches from an originator product to a biosimilar are typically authorized by the prescribing healthcare professional, subject to patient consent. In Latin America, medical societies have expressed concern about pharmacy-level substitution of biosimilars, 145,146 given its potential implications for pharmacovigilance and safety. 144 The product provided to the patient may be unknown to the recipient and the prescriber in many cases, 154 and substitution is a particular concern in countries where intended copies are in use.…”