5PSQ-202 Biosimilars in the real world: results from an active pharmacovigilance programme in a Portuguese oncology hospital
G Rigueiro, D Mendes, J Abrantes, AF Pais… - 2021 - ejhp.bmj.com
Background and importance The use of biologics is essential in the management of several
types of cancer. When patents of reference biologics expired, biosimilars emerged, widening …
types of cancer. When patents of reference biologics expired, biosimilars emerged, widening …
Real-world intensive safety monitoring of biosimilars rituximab and trastuzumab in a Portuguese oncology hospital
D Mendes, J Abrantes, G Rigueiro… - Journal of Oncology …, 2021 - journals.sagepub.com
Purpose The aim of this study was to assess the safety profiles of two biosimilar medicines
(rituximab and trastuzumab) in the treatment of cancer patients within a Portuguese …
(rituximab and trastuzumab) in the treatment of cancer patients within a Portuguese …
Comparative safety profiles of oncology biosimilars vs. originators in Europe: an analysis of the EudraVigilance Database
V Nikitina, G Santi Laurini, N Montanaro, D Motola - Cancers, 2023 - mdpi.com
Simple Summary Nowadays, biosimilar drugs are numerous and widely used in many
clinical fields, including oncology. However, skepticism remains towards these products …
clinical fields, including oncology. However, skepticism remains towards these products …
5PSQ-157 Expenditure and consumption descriptive analysis: rituximab originator versus biosimilar in an Italian district
S Alemanno, M Capilli, I Colasanto, D Fiorentino… - 2021 - ejhp.bmj.com
Background and importance The introduction of biological drugs changed the
pharmaceutical market, improving patients 'prognoses and quality of life. Intravenous …
pharmaceutical market, improving patients 'prognoses and quality of life. Intravenous …
Active postmarketing surveillance: Results from a manufacturer's patient support program for patients under treatment with the first biosimilar trastuzumab (MYL-1401O …
AM Silva, GVC Dib, ELF Saraiva, TT Watanabe… - 2019 - ascopubs.org
e14000 Background: The development of biosimilars is increasing around the world, and
facilitates patient's access to these high-tech therapies. Active pharmacovigilance is …
facilitates patient's access to these high-tech therapies. Active pharmacovigilance is …
Biosimilar trastuzumab active post marketing surveillance real world 2020 data update: Results from a patient support program for patients under treatment with the …
AM Silva, TTWO Watanabe, E Honda, J Yamaguchi - 2021 - ascopubs.org
e14504 Background: In 2017, biosimilar trastuzumab (Zedora) became the first biosimilar
trastuzumab approved in Brazil. In May 2018 an active postmarketing surveillance program …
trastuzumab approved in Brazil. In May 2018 an active postmarketing surveillance program …
[HTML][HTML] RITUXIMAB BIOSIMILAR RTXM83 POST-MARKETING SURVEILLANCE IN BRAZIL: EVALUATION OF THE ADVERSE EVENTS SPONTANEOUSLY …
AM Silva, E Honda, T Watanabe, A Borsoi - Hematology, Transfusion and …, 2021 - Elsevier
Background Biosimilars are highly similar to their reference products, but unlike generic
drugs, they are not identical. Differences between a biosimilar and its reference product may …
drugs, they are not identical. Differences between a biosimilar and its reference product may …
Extrapolation of indications and drug interchangeability as barriers to use trastuzumab-dkst biosimilar in Brazil.
HM Resende, P Cardoso, P Marassi, MS Precivale… - 2020 - ascopubs.org
e13010 Background: Brazil has a complex health-care system which comprises 76% of
population in the public unified health system (SUS) and only 24% in private system. Even …
population in the public unified health system (SUS) and only 24% in private system. Even …
Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First …
S Sagi, P Anjaneya, S Kalsekar, A Kottke, HP Cohen - Drug Safety, 2023 - Springer
Background Biosimilars are additional treatment options that are approved based on robust
analytical and clinical comparisons with their reference biologic. At the time of initial …
analytical and clinical comparisons with their reference biologic. At the time of initial …
Post-Marketing Safety of Innovative Drugs: Analysis of Pembrolizumab Related ADRs in a University Hospital
R Impagljatelli, V Calderone, M Olivero, BA Rita… - Drug …, 2022 - search.proquest.com
Introduction: Innovative drugs represent the most advanced pharmacological treatment
available for patients since these drugs are characterised by a benefit and a therapeutic …
available for patients since these drugs are characterised by a benefit and a therapeutic …