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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body: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...
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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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Body: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...
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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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...
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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Bioequivalence: Overview01:16

Bioequivalence: Overview

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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,...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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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,...
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Updated: Dec 22, 2025

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Upcoming Drifts in Bio-similars.

Geeta Aggarwal1, Manju Nagpal2, Ameya Sharma2

  • 1Delhi Pharmaceutical Sciences and Research University, New Delhi-110017, India.

Current Reviews in Clinical and Experimental Pharmacology
|May 8, 2020
PubMed
Summary
This summary is machine-generated.

Biosimilars, copies of original biologics, are emerging as the market expands. Their development is crucial for competition, meeting demand, and sustaining healthcare innovation.

Keywords:
BiologicsEMAFDAbiosimilarsglobal market.regulatory

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Area of Science:

  • Pharmacology
  • Biotechnology
  • Healthcare Economics

Background:

  • Biologics have been vital in treating metabolic and degenerative diseases for over 30 years.
  • The biologics market is projected to grow over 20% annually, with biologics comprising over 50% of new drug approvals by 2025.
  • Increasing biologic utilization necessitates cost control, driving the need for biosimilars.

Purpose of the Study:

  • To review the quality requirements, regulatory status, and challenges of biosimilar development.
  • To compile information on the therapeutic applications, regulatory guidelines, and market trends of biosimilars.
  • To assess the potential impact of biosimilars on the healthcare market.

Main Methods:

  • Systematic review of peer-reviewed articles.
  • Analysis of data from PubMed, EMA, FDA, and Indian regulatory bodies.
  • Inclusion of latest news and guidelines relevant to biosimilars.

Main Results:

  • Key quality requirements for biologics have been identified.
  • The current regulatory landscape for biosimilars and associated challenges are detailed.
  • Therapeutic status, regulatory pathways, and emerging trends for biosimilars are comprehensively presented.

Conclusions:

  • Updates on biosimilars are essential for understanding their market impact.
  • Biosimilars are poised to enhance market competition and meet global demand.
  • The development of biosimilars supports healthcare sustainability and innovation incentives.