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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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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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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars: Practical Considerations for Pharmacists.

James G Stevenson1,2, Robert Popovian3, Ira Jacobs4

  • 11 College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.

The Annals of Pharmacotherapy
|February 9, 2017
PubMed
Summary
This summary is machine-generated.

Biosimilars offer safe and effective treatment options for serious diseases. Pharmacists are crucial for understanding biosimilar development and regulatory guidelines to ensure informed use and patient education.

Keywords:
biotechnologyclinical practiceformularylegal/regulatory issuespostmarketing surveillance

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Area of Science:

  • Pharmaceutical Science
  • Regulatory Science
  • Clinical Pharmacy

Background:

  • Biologic therapies have transformed treatment for hematological disorders, autoimmune diseases, and cancers.
  • Biosimilars are highly similar to licensed biologics with no clinically meaningful differences in safety, purity, or potency.

Purpose of the Study:

  • To review the scientific and regulatory aspects of biosimilar development.
  • To outline practical considerations for the use of biosimilars relevant to pharmacists.

Main Methods:

  • Conducted literature searches of PubMed and congress abstracts (January 2016-January 2017).
  • Reviewed drug company websites, governmental, and regulatory agency resources.
  • Included articles and guidelines on biologic/biosimilar development, approval, and studies.

Main Results:

  • Biologics are large, complex proteins, making exact replication impossible, unlike small-molecule drugs.
  • Regulatory agencies have established frameworks for biosimilar approval.
  • Key considerations for pharmacists include interchangeability, substitution, naming, indication extrapolation, labeling, drug monitoring, manufacturer attributes, logistics, and reimbursement.

Conclusions:

  • Pharmacists play a vital role in integrating biosimilars into healthcare systems.
  • Understanding biosimilar development and regulatory guidelines enables informed decisions on formulary inclusion and education for patients and providers.