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Drug Products: Biologics, Biosimilars and Interchangeables01:28

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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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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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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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Bioequivalence studies: Biowaivers01:13

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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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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.
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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...
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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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Biosimilars - terms of use.

Paul Declerck1, Håkan Mellstedt2, Silvio Danese3

  • 1a a Department of Pharmaceutical and Pharmacological Sciences , KU Leuven, University of Leuven , Leuven , Belgium.

Current Medical Research and Opinion
|September 24, 2015
PubMed
Summary
This summary is machine-generated.

The patent expiry of biologic drugs spurs biosimilar development. However, differences in molecular structure and manufacturing create global definition and evaluation challenges for these complex medicines.

Keywords:
BiologicsBiosimilarsInterchangeabilityPharmacovigilance

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Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • Patent expirations for biologic drugs are driving the development of biosimilar products.
  • Unlike generic drugs, biosimilars are not identical to their reference biologic products due to molecular and manufacturing complexities.

Purpose of the Study:

  • To clarify terminology surrounding biologic and biosimilar development and utilization.
  • To address the knowledge gap hindering quantitative evaluation and regulatory clarity for biosimilars.

Main Methods:

  • Literature review and analysis of global regulatory guidelines.
  • Comparative analysis of terminology used in different regions for biosimilar development and approval.

Main Results:

  • Identified significant inconsistencies in terminology related to biosimilar regulatory approval, pharmacovigilance, interchangeability, and treatment-naivety.
  • Highlighted the challenges in quantitative evaluation stemming from these definitional discrepancies.

Conclusions:

  • Standardized global definitions are crucial for the clear development, evaluation, and utilization of biosimilars.
  • Addressing these terminological gaps is essential for regulatory agencies and the scientific community to confidently advance biosimilar adoption.