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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the appropriate...
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug absorption...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...

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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Pharmacovigilance and biosimilars: considerations, needs and challenges.

Nicole Casadevall1, I Ralph Edwards, Thomas Felix

  • 1Hôpital Saint Antoine, Paris, France.

Expert Opinion on Biological Therapy
|March 27, 2013
PubMed
Summary

European experience with biosimilar pharmacovigilance offers crucial lessons for the US. Robust systems are needed for tracking biosimilars and their reference products to ensure patient safety and efficacy.

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Area of Science:

  • Pharmacovigilance
  • Biologics and Biosimilars
  • Regulatory Science

Background:

  • Biosimilars are highly similar biologic medicines approved in the EU since 2007.
  • European experience provides valuable insights for the US healthcare system's upcoming biosimilar approvals.
  • Lessons learned emphasize the need for rigorous efficacy, safety studies, and post-marketing surveillance.

Purpose of the Study:

  • To review European Union (EU) experience with biosimilar pharmacovigilance.
  • To discuss implications for biosimilar pharmacovigilance in the United States (US).
  • To examine key aspects of biosimilar pharmacovigilance, including traceability and system development.

Main Methods:

  • Review of EU biosimilar pharmacovigilance data and practices.
  • Analysis of implications for US biosimilar pharmacovigilance.
  • Examination of specific pharmacovigilance elements: cohort event monitoring, traceability, interchangeability, system development, nomenclature, and counterfeit tracking.

Main Results:

  • European experience highlights the necessity of robust pharmacovigilance for biosimilars.
  • Effective tracking and tracing of biosimilars and reference products are critical.
  • The US can benefit from EU's established practices in managing biosimilar safety and efficacy.

Conclusions:

  • Biosimilar availability necessitates careful consideration of safety, efficacy, and traceability.
  • Stringent pharmacovigilance is essential for detecting safety signal differences between biosimilars and reference products.
  • Pharmacovigilance systems must be user-friendly for practitioners to ensure accurate data reporting and product assignment.