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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: Overview

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,...

Biopharmaceutics and Pharmacokinetics: Overview

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...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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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, controlled...

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

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Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug absorption...

Bioequivalence studies: Biowaivers

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...

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Crystal structures of uninhibited factor VIIa link its cofactor and substrate-assisted activation to specific interactions.

Journal of molecular biology·2002

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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

Biosimilars--science, status, and strategic perspective.

Georg-Burkhard Kresse¹

¹Pharma Research, Roche Diagnostics GmbH, Penzberg, Germany. georg-burkhard.kresse@roche.com

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V

|March 17, 2009

Summary

This summary is machine-generated.

Follow-on biologics, known as biosimilars, are entering the market as original biopharmaceuticals lose patent protection. Regulatory frameworks are adapting to these complex protein-based therapies, differing from small-molecule drugs.

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Published on: December 1, 2020

Area of Science:

Biotechnology
Pharmacology
Regulatory Science

Background:

Recombinant protein biopharmaceuticals are increasingly going off-patent.
Biosimilars (follow-on biopharmaceutical products) present unique challenges compared to traditional small-molecule drugs.
Stakeholders recognize fundamental differences necessitating distinct regulatory approaches.

Purpose of the Study:

To review the scientific basis for biosimilar approval requirements.
To provide an overview of the current regulatory and market status of biosimilars.
To discuss open issues and strategic perspectives in the biosimilar landscape.

Main Methods:

Literature review of scientific publications.
Analysis of regulatory guidelines and market data.
Synthesis of information on scientific, regulatory, and market aspects.

Main Results:

Established scientific principles guide biosimilar approval.
Diverse regulatory frameworks exist globally for biosimilars.
Market entry and strategic considerations vary by region.

Conclusions:

Biosimilar development requires rigorous scientific evaluation.
Harmonization of regulatory pathways is an ongoing challenge.
Strategic planning is crucial for successful biosimilar market integration.