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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
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Biosimilars: A new scenario in biologic therapies
José M Serra López-Matencio1, Alberto Morell Baladrón1, Santos Castañeda2
1Servicio de Farmacia Hospitalaria, Hospital de La Princesa, IIS-IP, Universidad Autónoma, Madrid, España.
Reumatologia Clinica
|July 4, 2016
Summary
Biologic therapies and biosimilars require rigorous quality control. Pharmacovigilance and traceability are crucial for monitoring their safety and detecting adverse events in clinical practice.
Area of Science:
- Pharmacology and Health Systems Management
Background:
- Biologic therapies offer significant value to healthcare systems.
- Their complex nature necessitates stringent quality control and monitoring.
- The emergence of lower-cost biosimilars increases market impact and necessitates careful oversight.
Purpose of the Study:
- To review manufacturing, distribution, and control system challenges for biologics and biosimilars.
- To examine safety aspects of these products in clinical practice.
- To assess pharmacovigilance, emphasizing traceability for early adverse event detection.
Main Methods:
- Literature review of manufacturing, distribution, and control systems.
- Analysis of clinical safety data for biologics and biosimilars.
- Evaluation of pharmacovigilance strategies, focusing on traceability.
Main Results:
- Biologics and biosimilars present unique manufacturing and distribution challenges.
- Rigorous quality control and monitoring are essential for safe clinical use.
- Traceability is a vital component of pharmacovigilance for timely adverse event identification.
Conclusions:
- Effective pharmacovigilance systems, particularly those with robust traceability, are indispensable for ensuring the safety of biologic therapies and biosimilars.
- Addressing manufacturing, distribution, and control system issues is key to maximizing the value of these important medical treatments.
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