Adverse event reporting of marketed biosimilar and biological monoclonal antibody cancer treatments in the United States
ABSTRACT Background By 8 September 2022, 10 biological monoclonal antibody (mAb)
biosimilar products for cancer treatment had been approved and marketed in the United …
biosimilar products for cancer treatment had been approved and marketed in the United …
Safety of marketed biosimilar monoclonal antibody cancer treatments in the US: a disproportionality analysis using the food and drug administration adverse event …
X Xue, J Qian - Expert Opinion on Drug Safety, 2024 - Taylor & Francis
ABSTRACT Background By 31 December 2022, the United States Food and Drug
Administration (FDA) has approved 12 biosimilar monoclonal antibody cancer treatments …
Administration (FDA) has approved 12 biosimilar monoclonal antibody cancer treatments …
[HTML][HTML] Uptake of trastuzumab biosimilars for the treatment of HER2-positive breast cancer: a real-world experience from a cancer center
M Piezzo, R D'Aniello, I Avallone, B Barba… - Pharmaceutics, 2021 - mdpi.com
Background: The introduction of trastuzumab biosimilars in clinical practice plays an
important role in promoting the sustainability of healthcare systems. By contrast, the …
important role in promoting the sustainability of healthcare systems. By contrast, the …
Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study
MH Park, JH Seo, JH Park, MK Seong… - Expert opinion on …, 2024 - Taylor & Francis
Background The trastuzumab biosimilar CT-P6 is approved for human epidermal growth
factor receptor 2 (HER2)–positive early breast cancer (EBC), metastatic breast cancer …
factor receptor 2 (HER2)–positive early breast cancer (EBC), metastatic breast cancer …
A developer's perspective on clinical evidence and benefits for rituximab biosimilar uptake, with a focus on CT-P10
D Choi, S Lee, S Kim, S Yoon - Clinical Drug Investigation, 2022 - Springer
To date, four rituximab biosimilars have received regulatory approval from the European
Medicines Agency and/or US Food and Drug Administration. CT-P10 was the first rituximab …
Medicines Agency and/or US Food and Drug Administration. CT-P10 was the first rituximab …
A non-interventional, post-marketing surveillance study evaluating the safety and effectiveness of biosimilar rituximab (CT-P10) during routine clinical practice in the …
JC Jo, Y Jeon, DJ Kim, DH Yang, WS Lee… - Expert Opinion on …, 2023 - Taylor & Francis
Background CT-P10 was the first licensed rituximab biosimilar. This Korean post-marketing
surveillance study evaluated CT-P10 safety and effectiveness in approved indications …
surveillance study evaluated CT-P10 safety and effectiveness in approved indications …
[PDF][PDF] Real-World Evidence of Biosimilar Utilisation and Pharmacoeconomics in People Living with Breast or Lung Cancer
HJ Moir - emjreviews.com
As the medical community continues to explore and harness the potential of biosimilars, it is
imperative to accumulate robust real-world evidence (RWE) to guide informed decision …
imperative to accumulate robust real-world evidence (RWE) to guide informed decision …