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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,...
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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...
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Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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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...

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Biosimilars: what clinicians should know.

Martina Weise1, Marie-Christine Bielsky, Karen De Smet

  • 1Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn, Germany. martina.weise@bfarm.de

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Summary
This summary is machine-generated.

Biosimilar medicines are becoming available, but many doctors hesitate due to concerns about quality, safety, and efficacy. Understanding biosimilar principles and unbiased data is crucial for informed clinical decisions.

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Area of Science:

  • Pharmacology
  • Immunology
  • Regulatory Science

Background:

  • Biosimilar medicinal products (biosimilars) are increasingly available in the EU and US.
  • Clinicians, especially oncologists, express reluctance towards adopting biosimilars.
  • Concerns include pharmaceutical quality, safety (immunogenicity), efficacy (extrapolation), and interchangeability.

Purpose of the Study:

  • To address clinician concerns regarding biosimilar medicinal products.
  • To clarify the scientific principles and regulatory landscape of biosimilars.
  • To promote informed treatment choices by physicians.

Main Methods:

  • Review of regulatory guidance and scientific principles for biosimilar development.
  • Expert panel discussion addressing key concerns voiced by clinicians.
  • Analysis of data requirements for biosimilar licensing.

Main Results:

  • The article clarifies the scientific basis for biosimilar approval.
  • It addresses concerns about pharmaceutical quality, safety, efficacy, and interchangeability.
  • Highlights the importance of unbiased information for physicians.

Conclusions:

  • Physicians need a clear understanding of biosimilar science and unbiased data for informed decision-making.
  • Improved communication between physicians, societies, and regulators is essential.
  • The advent of biosimilar monoclonal antibodies necessitates greater physician awareness and acceptance.