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Drug Products: Biologics, Biosimilars and Interchangeables

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 studies: Biowaivers

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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 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 of Drugs: Drugs with Multiple Indications

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Related Experiment Video

Updated: Jun 3, 2026

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

Worldwide experience with biosimilar development.

Mark McCamish¹, Gillian Woollett

¹Sandoz Biopharmaceuticals, Sandoz International GmbH, Holzkrichen, Germany.

|March 29, 2011

Summary

This summary is machine-generated.

Biosimilars offer high-quality, lower-cost biologic medicines, addressing unmet needs. The US FDA pathway approval facilitates patient access and supports pharmaceutical innovation.

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Published on: December 1, 2020

Area of Science:

Biopharmaceutical industry
Regulatory science
Health economics

Background:

High cost of biologic treatments creates an unmet medical need globally.
Biosimilars are follow-on biologics meeting strict comparability standards.
Expiring patents on complex biologics, like monoclonal antibodies, enable biosimilar development.

Purpose of the Study:

To discuss the establishment of a regulatory pathway for biosimilars in the US.
To highlight the role of biosimilars in reducing treatment costs.
To emphasize the FDA's leadership in biosimilar approval and interchangeability designation.

Main Methods:

Review of regulatory frameworks for biosimilar approval (FDA, EMA).
Analysis of the economic impact of biosimilar adoption.
Examination of the Biologics Price Competition and Innovation Act.

Main Results:

Biosimilar utilization has decreased treatment costs internationally.
A regulatory pathway for biosimilar approval now exists in the US.
The FDA's comparability concept and EMA's application are foundational.

Conclusions:

FDA approval of biosimilars is crucial for patient access to quality biologics.
Biosimilars enable affordability of innovative medicines.
The regulatory landscape supports increased competition and patient access.