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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

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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.
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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: Biowaivers01:13

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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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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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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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[Biosimilars: opportunities and risks].

R Grieshaber-Bouyer1, H-M Lorenz2

  • 1Medizinische Klinik V, Klinik für Hämatologie, Onkologie und Rheumatologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 410, 69120, Heidelberg, Deutschland. ricardo.grieshaberbouyer@med.uni-heidelberg.de.

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Summary

Biosimilars offer safe and economical alternatives to original biologic drugs. These highly similar therapies increase access to advanced treatments and reduce healthcare costs.

Keywords:
Biological productsBiosimilar pharmaceuticals, safetyBiosimilar pharmaceuticals, treatment outcomeDrug costsImmunogenicity

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Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Immunology
  • Pharmacoeconomics

Background:

  • Biologic therapies are crucial for managing chronic and immune-mediated diseases.
  • Biosimilars are highly similar versions of approved biologic therapies, entering the market after patent expiry.

Purpose of the Study:

  • To review the role of biosimilars in modern medicine.
  • To present data on the efficacy and safety of biosimilars.

Main Methods:

  • Analysis of approved biologic therapies and biosimilars in the European Union.
  • Assessment of economic impact, including healthcare costs and potential savings.
  • Evaluation of efficacy, safety, and immunogenicity data for biosimilars.

Main Results:

  • Over 150 biologic therapeutics and 50 biosimilars (of 16 biologics) are approved in the EU.
  • Biologics represent one-third of German drug expenditure (13.8 billion Euros annually).
  • Biosimilars demonstrate no clinically relevant differences in efficacy, safety, or immunogenicity compared to originators, with estimated savings of 500 million Euros in Germany.

Conclusions:

  • Biosimilars provide safe and cost-effective alternatives to original biologic drugs.
  • They enhance patient access to advanced, high-cost therapies.
  • Biosimilars contribute to relieving the financial burden on healthcare systems.