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Related Concept Videos

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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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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Equivalence: In Vitro and In Vivo Bioequivalence01:17

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Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts. Pharmaceutical...
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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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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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Biosimilars: are they bioequivalent?

Fernando Gomollón1

  • 1IBD Unit, Digestive Diseases Service, Hospital Clínico Universitario 'Lozano Blesa', IIS Aragón, CIBEREHD, Zaragoza, Spain.

Digestive Diseases (Basel, Switzerland)
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Biosimilars offer cheaper alternatives to complex biologic drugs, potentially improving patient access. Regulatory approval varies globally, impacting their availability for conditions like Crohn

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Area of Science:

  • Biotechnology and Pharmaceutical Sciences
  • Immunology and Inflammatory Diseases
  • Regulatory Science

Background:

  • Biologic therapies, including monoclonal antibodies, have transformed medical treatment, with numerous agents in development.
  • Biosimilars, copies of biologics, are increasingly entering the market but face complex manufacturing and stringent regulatory scrutiny.
  • The approval and acceptance of biosimilars vary significantly among regulatory bodies, impacting patient access.

Purpose of the Study:

  • To review the development and regulatory landscape of biosimilars, focusing on infliximab in inflammatory bowel disease (IBD).
  • To examine the differing approaches of regulatory agencies like the EMA and Canadian authorities regarding biosimilar extrapolation.
  • To discuss practical considerations and future implications of biosimilar adoption in healthcare.

Main Methods:

  • Review of regulatory guidelines and scientific literature on biosimilar development and approval.
  • Analysis of the EMA's decision to approve biosimilar infliximab based on extrapolation from other indications.
  • Examination of Canadian authorities' concerns regarding glycosylation differences and extrapolation for Crohn's disease.

Main Results:

  • The European Medicines Agency (EMA) approved biosimilar infliximab for IBD indications based on similarity and data from other conditions.
  • Canadian authorities did not accept extrapolation for infliximab, citing potential differences in glycosylation impacting efficacy in Crohn's disease.
  • Scientific societies generally support specific clinical trials but acknowledge the safety of products approved under EMA, FDA, and WHO guidelines.

Conclusions:

  • Biosimilar approval and extrapolation policies differ globally, affecting market entry and patient access.
  • Interchangeability and substitution of biosimilars present practical challenges requiring national-level solutions.
  • Robust pharmacovigilance is crucial for gathering data and ensuring the safe integration of biosimilars into clinical practice, potentially lowering treatment costs.