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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

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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 indication due to...
Pharmaceutical Equivalents01:26

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: 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,...
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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Laboratory Scale Production and Purification of a Therapeutic Antibody
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Biosimilar therapeutics-what do we need to consider?

Huub Schellekens1

  • 1Departments of Pharmaceutical Sciences and Innovation Studies , Utrecht University , Utrecht , The Netherlands.

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Generic biopharmaceuticals, known as biosimilars, are entering the market as innovator drug patents expire. Healthcare professionals must understand biosimilar complexities, including structural verification and immunogenicity, for safe and effective patient treatment.

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Area of Science:

  • Biopharmaceuticals
  • Pharmacology
  • Regulatory Science

Background:

  • Patents for originator biopharmaceuticals are expiring, leading to the market introduction of biosimilars (EU) and follow-on protein products (US).
  • Biopharmaceuticals' complex structures, heterogeneity, and production methods differ significantly from small-molecule drugs, posing analytical challenges for equivalence confirmation.
  • Immunogenicity, a critical safety concern for biopharmaceuticals, necessitates rigorous testing and post-marketing surveillance.

Purpose of the Study:

  • To highlight the challenges and considerations for healthcare professionals regarding the use of biosimilars.
  • To discuss the regulatory hurdles and scientific complexities in approving biosimilar products.
  • To address outstanding issues such as interchangeability, naming conventions, and labeling.

Main Methods:

  • Review of current analytical limitations in characterizing complex biopharmaceuticals.
  • Analysis of regulatory guidelines, specifically those from the European Medicines Agency (EMEA).
  • Discussion of safety aspects, including immunogenicity assessment and post-marketing surveillance.

Main Results:

  • Current analytical methods are insufficient to definitively confirm structural equivalence between biosimilars and reference products.
  • Regulatory approval of biosimilars involves a rigorous process, with the EMEA providing guidance.
  • Key challenges remain, including demonstrating interchangeability, unique product naming, and comprehensive labeling.

Conclusions:

  • Verification of biosimilar similarity to innovator biopharmaceuticals is a significant challenge.
  • Robust immunogenicity testing and post-marketing surveillance are crucial for biosimilar safety.
  • Further regulatory clarity is needed on interchangeability, naming, and labeling to ensure informed clinical decision-making.