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Related Concept Videos

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...
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...
Bioequivalence: Overview01:16

Bioequivalence: Overview

Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

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Updated: May 30, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
07:25

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Biosimilar peptides: need for pharmacovigilance.

Shashank R Joshi1

  • 1Joshi Clinic, Lilavati & Bhatia Hospital, Grant Medical College Mumbai, India.

The Journal of the Association of Physicians of India
|August 9, 2011
PubMed
Summary

Biosimilar medicines are copies of biologic drugs, facing strict regulations. Current data is insufficient to determine their clinical impact, necessitating further research and pharmacovigilance.

Area of Science:

  • Pharmaceutical Science
  • Biotechnology
  • Regulatory Affairs

Background:

  • Biosimilars are highly similar versions of approved biologic medicines, manufactured using distinct processes.
  • Producing biosimilars involves complex fermentation and protein folding, differing from traditional chemical synthesis.
  • Regulatory bodies like the U.S. FDA and European Medicines Agency (EMEA) enforce stringent approval mandates.

Purpose of the Study:

  • To review the nature of biosimilar development and regulatory requirements.
  • To highlight the challenges in creating bioidentical molecules due to complex manufacturing.
  • To emphasize the need for clinical validation and pharmacovigilance of biosimilars, particularly in endocrinology.

Main Methods:

  • Review of biosimilar manufacturing processes, including fermentation and protein folding.

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  • Analysis of regulatory standards set by agencies such as the U.S. FDA and EMEA.
  • Examination of existing data on clinical relevance and side effects of biosimilars.

    • Main Results:

    • Biosimilars are near-identical but not bioidentical to originator biologics due to separate manufacturing processes.
    • Significant differences exist in manufacturing and protein folding, making exact replication challenging.
    • There is currently limited data on the clinical relevance and potential side effects of biosimilars.

    Conclusions:

    • The complex 3-D structure of biomolecules presents unique challenges for biosimilar development and regulation.
    • Further evidence-based validation is required to confirm the clinical efficacy and safety of biosimilars.
    • Close pharmacovigilance is essential for monitoring biosimilar performance in real-world settings, especially for products like insulin and growth hormones.