Brazilian Society of Clinical Oncology Issues Position on Biosimilars

The Brazilian Society of Clinical Oncology (SBOC) has released its official position on the use of biosimilars in oncology. Thus far, only 2 oncology biosimilars (filgrastim and trastuzumab) have been approved for use in Brazil, though the number of applications filed with the National Health Surveillance Agency (ANVISA) is expected to grow steadily in the coming years.

SBOC addresses the following issues in its position statement:

Cost. According to SBOC, “The costs of treatment incurred by cancer patients, their families, and public and private healthcare providers are prohibitive. The high cost of biopharmaceuticals, especially ‘monoclonal molecules’ like rituximab, account for most of the cost of cancer treatment,” and biosimilars could produce substantial savings (estimated at a 10% to 35% reduction off the price of the reference drug), which is particularly important in the economy of Brazil, where publicly funded healthcare is a constitutional right.

Extrapolation of indications. Extrapolation for each proposed indication should be supported by evidence from a randomized phase 3 trial. However, because such studies are not always feasible or practical, SBOC recognizes that the extrapolation of indications should be weighed carefully, on a case-by-case basis, by regulatory authorities.

Interchangeability. SBOC holds that, whenever possible, patients should remain on the same biologic therapy throughout their treatment. However, if it is not possible to keep a patient on the same drug, treating biosimilars as interchangeable in a given patient should only occur under “strict conditions,” involving the approval of the attending physician, the awareness of the patient, and “without interference from the pharmacist.”

Nomenclature. Because biosimilars will likely outnumber reference products at some point in the future, the use of identical nonproprietary names for biosimilar may lead to inaccuracies in record keeping. SBOC suggests that biosimilars’ names carry identifying features that will enable good pharmacovigilance.

Pharmacovigilance. It is critical to implement a tracking system for biologics and biosimilars, and current pharmacovigilance systems in Brazil are not adequate for the task of tracking these products, says SBOC.

Clinical trials. Though survival outcomes are preferable in phase 3 trials, other endpoints, such as pathological complete response or progression-free survival, may be sufficient to show the safety and efficacy of oncology biosimilars.

Education. There exists an urgent need to implement training on biosimilars and pharmacovigilance in medical schools, and to train working healthcare providers on these products. “In addition, a cultural shift in the Brazilian medical community to the importance of reporting adverse events that may be associated with the use of biosimilars is crucial,” says SBOC. Pharmacovigilance issues should be address in medical meetings and congresses, and biosimilar developers should play an active role in pharmacovigilance efforts.

Economic impact. Cost-minimization analyses are appropriate to compare biosimilars and reference biologics to identify the treatment that can be provided at the lowest cost.

Harmonization. Global harmonization of regulatory requirements is key to wide acceptance of biosimilars, which may lead to cost reductions.

In concluding its position, SBOC said that it “…takes a stand in favor of the introduction of biosimilars,” and that it hopes its position can provide valuable information to support therapeutic decisions that maximize clinical benefit for patients and expedite the introduction of biosimilars in clinical practice.