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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,...

Pharmaceutical Equivalents

Pharmaceutical Equivalents

As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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...

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...

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...

Bioequivalence of Drugs: Drugs with Multiple Indications

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...

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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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Endogenous versus exogenous generic reference pricing for pharmaceuticals.

F Antoñanzas¹, C A Juárez-Castelló¹, R Rodríguez-Ibeas²

¹Department of Economics, University of La Rioja, 26004, Logroño, Spain.

International Journal of Health Economics and Management

|May 17, 2017

Summary

Reference pricing in pharmaceutical markets enhances competition. Health authorities should favor exogenous over endogenous systems, with optimal choices depending on whether authorities are paternalistic.

Keywords:

Endogenous reference price Exogenous reference price Generic drug Off-patent drug Pharmaceutical expenditures

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Area of Science:

Health Economics
Pharmaceutical Policy
Industrial Organization

Background:

Pharmaceutical markets feature competition between branded and generic drugs.
Reference pricing systems are policy tools used to control drug expenditures.

Purpose of the Study:

To analyze the impact of endogenous and exogenous generic reference pricing on competition.
To compare the welfare implications of different reference pricing systems.

Main Methods:

Vertical differentiation duopoly model applied to pharmaceutical markets.
Equilibrium price characterization for exogenous reference pricing.
Welfare analysis under different health authority objective functions.

Main Results:

Reference pricing systems enhance competition between generic and branded drugs.
Health authorities should not choose endogenous reference pricing.
Optimal exogenous reference prices differ based on paternalism and welfare objectives.

Conclusions:

Exogenous reference pricing is superior to endogenous systems for health authorities.
Policy design for exogenous reference pricing must consider health authority objectives and paternalism.