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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...
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 of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each indication due to...
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
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...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

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 pharmacologically...

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Related Experiment Video

Updated: Jun 13, 2026

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

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

Published on: May 4, 2017

Biosimilars: current status and future directions.

Simon D Roger1

  • 1Renal Unit, Gosford Hospital, Holden Street, Gosford, 2250, NSW, Australia. sroger@nsccahs.health.nsw.gov.au

Expert Opinion on Biological Therapy
|April 14, 2010
PubMed
Summary
This summary is machine-generated.

Biosimilar medicines offer wider access to expensive biopharmaceuticals, but clinicians must remain vigilant against non-transparent promotion of both innovator and biosimilar products. This review examines regulatory approaches and controversies surrounding biosimilars.

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Related Experiment Videos

Last Updated: Jun 13, 2026

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

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

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Area of Science:

  • Biopharmaceutical development
  • Drug regulatory affairs

Background:

  • Patent expirations for biopharmaceuticals create opportunities for biosimilar development.
  • Concerns exist regarding biosimilar similarity and their potential to reduce healthcare costs.

Purpose of the Study:

  • To review global regulatory approaches, manufacturing considerations, and immunogenicity of biosimilars.
  • To outline strategies used by pharmaceutical companies to promote or challenge biosimilar adoption.
  • To discuss limitations in post-marketing surveillance of biosimilars.

Main Methods:

  • Review of regulatory frameworks and scientific literature on biosimilars.
  • Analysis of arguments and tactics in the promotion and discrediting of biosimilar drugs.
  • Examination of post-marketing surveillance programs and their constraints.

Main Results:

  • Controversial issues surrounding biosimilar introduction across various indications are highlighted.
  • Differences between regulatory-approved biosimilars and non-regulated biopharmaceutical products are identified.
  • The rapid evolution of biosimilar regulatory approval and licensing presents a limitation.

Conclusions:

  • Biosimilar medicines hold promise for increasing the availability of costly biopharmaceutical treatments.
  • Healthcare providers should exercise caution regarding undisclosed promotional activities for both originator and biosimilar products.