Dados do Trabalho

Título

POST MARKETING PHARMACOVIGILANCE OF A TRASTUZUMAB BIOSIMILAR IN BRAZIL. PROFILE AND ANALYSIS OF ADVERSE EVENTS REPORTED.

Introdução

Biosimilars are highly similar to their reference products, but not identical like generic drugs. Differences between a biosimilar and its reference product may arise because of the complexity of biologics and differences in the cell lines and processes during manufacturing. Biosimilars are approved in the Europe, USA and Brazil through a regulatory pathway based on comparative analytical and clinical studies. Post marketing pharmacovigilance is a useful tool to confirm the safety profile of biosimilar medication.

Objetivo

The purpose of this communication is to present the data collected during post-marketing pharmacovigilance activities from the first trastuzumab biosimilar approved in Brazil.

Método

Post-marketing surveillance methods, active and passive, were used to identify adverse events (AEs). AEs were spontaneously reported by health professionals and non-health professionals and were also collected through a patient support program. Descriptive analysis of AEs was performed.

Resultado

Between March 2018 and May 2021 a total of 146 reports (3 male and 143 female) with 1016 AEs were received: 57 from routine pharmacovigilance and 89 from active pharmacovigilance. Average age 57 (24 to 93) years old, 143 diagnosed with initial or advanced HER2+ breast cancer (BC) and 3 with advanced gastric cancer. Considering all 1016 AEs: 899 (88.4%) were non-serious (635/62,5% expected and 264/25,9% unexpected) and 117 (11,5%) serious (85/8,3% expected and 32/3,1% unexpected). The most frequently reported AEs according SOC (system organ classification) were general disorder and administration site condition 169 (16,6%), gastrointestinal disorder 165 (16,2%), nervous system disorders 124 (12,2%), investigation 84 (8,3%) and skin and subcutaneous tissue disorders 77 (7,6%). The most reported AEs (by MedDRA PT- Preferred term) were diarrhoea 42 (4,1%), fatigue 37 (3,6%), nausea 36 (3,5%), infusion related reaction 32 (3,1%), headache 23 (3,5%).

Conclusão

The profile of AEs reported for biosimilar trastuzumab in female patients with HER2+ breast cancer and male patients with advanced gastric cancer demonstrated similarity to its originator, based on literature data and the Summary of Product Characteristics (SmPC) of the reference product. Most of the reported AEs were non-serious (88, 4%) and expected (70,8%). No new serious unexpected related adverse events, trends or signals were observed, and incidence of AEs is in line with the label.

Palavras-chave

pharmacovigilance, trastuzumab, biosimilar