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Drug Products: Biologics, Biosimilars and Interchangeables

Drug Products: Biologics, Biosimilars and Interchangeables

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...

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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Bioequivalence studies: Biowaivers

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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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...

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Body:Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts.

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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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Published on: May 4, 2017

Science of Biosimilars.

R Donald Harvey¹

¹Winship Cancer Institute of Emory University, Atlanta, GA.

Journal of Oncology Practice

|September 13, 2017

Summary

Biosimilar therapeutic proteins offer lower costs with similar safety and efficacy to reference products. Unique manufacturing requires rigorous analysis and post-market surveillance for oncology biosimilars.

Area of Science:

Biotechnology and Pharmaceutical Sciences
Oncology Therapeutics
Regulatory Science

Background:

Biosimilar therapeutic proteins in oncology present opportunities for cost reduction while maintaining safety and efficacy comparable to reference products.
Unlike generic small-molecule drugs, biosimilars involve unique manufacturing processes that can influence posttranslational modifications, affecting protein structure, function, clinical pharmacology, and immunogenicity.

Purpose of the Study:

To discuss the unique aspects of biosimilar development and regulation in oncology.
To highlight the importance of rigorous preclinical evaluation and post-marketing surveillance for biosimilars.
To inform prescribers about the detailed labeling and pharmacovigilance requirements for biosimilar agents.

Main Methods:

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Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

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

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

Published on: May 4, 2017

Laboratory Scale Production and Purification of a Therapeutic Antibody

Laboratory Scale Production and Purification of a Therapeutic Antibody

Published on: January 24, 2017

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Biosensor-based High Throughput Biopanning and Bioinformatics Analysis Strategy for the Global Validation of Drug-protein Interactions

Published on: December 1, 2020

Review of regulatory expectations for biosimilar development, focusing on identifying and minimizing manufacturing-related differences.

Analysis of naming conventions and labeling requirements for biosimilars to ensure clarity for healthcare providers.

Discussion of the need for enhanced post-marketing surveillance to monitor potential adverse events.

Main Results:

Regulatory agencies mandate extensive preclinical assessment to address manufacturing variability and its impact on biosimilar characteristics.
Biosimilar labeling provides detailed comparisons to reference products, aiding prescriber understanding of therapeutic profiles.
Post-marketing surveillance strategies must adapt to manage the unique risks associated with biosimilars.

Conclusions:

Biosimilars in oncology, including upcoming monoclonal antibodies, require careful evaluation due to manufacturing differences.
Robust regulatory oversight and pharmacovigilance are crucial for ensuring the safe and effective use of biosimilars.
The evolving landscape of biosimilars necessitates continuous adaptation of regulatory and clinical practices.