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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...
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Vaccines are among the most effective tools in preventive medicine, designed to prepare the immune system to recognize and combat infectious agents. By introducing antigens—substances that the immune system identifies as foreign—vaccines stimulate an adaptive immune response that leads to immunological memory. This immunological memory enables the body to mount a faster and more effective response upon future exposures to the actual pathogen.Vaccines can be categorized based on the type of...
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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Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Vaccines and biosimilarity: a solution or a problem?

Michael J Corbel1, Maria de Los Angeles Cortes Castillo

  • 1Division of Bacteriology, National Institute for Biological Standards and Control, Potters Bar, Hertfordshire, EN6 3QG, UK. mcorbel@nibsc.hpa.org.uk

Expert Review of Vaccines
|October 7, 2009
PubMed
Summary
This summary is machine-generated.

Defining biosimilarity for vaccines requires careful consideration. Current biotherapeutic guidelines may be too restrictive, necessitating vaccine-specific criteria for regulatory approval of follow-on products.

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Area of Science:

  • Vaccinology
  • Immunology
  • Regulatory Science

Background:

  • Biosimilarity is crucial for vaccine development, impacting licensing of follow-on products.
  • Existing biotherapeutic biosimilarity criteria may not be suitable for vaccines due to complex molecular composition and the essential role of immunogenicity.

Purpose of the Study:

  • To review and define biosimilarity criteria specifically for vaccines.
  • To address challenges in licensing follow-on vaccine products.
  • To emphasize the need for vaccine-specific regulatory guidelines.

Main Methods:

  • Review of current bacterial and viral vaccine types.
  • Analysis of existing biosimilarity definitions and guidelines for biotherapeutics.
  • Consideration of antigenic composition and immunogenicity in vaccine biosimilarity.

Main Results:

  • Current biosimilarity definitions for biotherapeutics are likely too restrictive for vaccines.
  • Antigenic similarity may be a more relevant criterion than precise molecular definition.
  • Superficial similarity can mask significant performance differences, requiring clinical evaluation.

Conclusions:

  • Vaccine biosimilarity requires tailored definitions and guidelines, distinct from biotherapeutics.
  • Limited clinical studies, allowing side-by-side comparisons, could be acceptable for biosimilar vaccines.
  • Development of enhanced regulatory tests is needed to detect subtle, biologically significant differences in vaccines.