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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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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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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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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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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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Biopharmaceutics and Pharmacokinetics: Overview01:28

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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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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Will biosimilars gain momentum?

Bradford R Hirsch1, Gary H Lyman

  • 1From the aDuke Clinical Research Institute, bDuke Cancer Institute, and cDuke University, Durham, North Carolina.

Journal of the National Comprehensive Cancer Network : JNCCN
|October 22, 2013
PubMed
Summary
This summary is machine-generated.

Biosimilars offer potential cost savings and improved access in oncology. Understanding regulatory hurdles and clinical data requirements is crucial for their US market introduction and clinician adoption.

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Area of Science:

  • Oncology
  • Pharmacoeconomics
  • Regulatory Science

Background:

  • Biosimilars, or follow-on biologics, are gaining interest in oncology for potential cost reductions and enhanced patient access.
  • Significant confusion persists regarding biosimilar market entry in the United States, compounded by regulatory and legal challenges.
  • The European Union established an approval pathway in 2004, leading to the market availability of several biosimilar agents.

Purpose of the Study:

  • To clarify the complexities surrounding biosimilar introduction in the US oncology market.
  • To examine the regulatory landscape and clinical data requirements for biosimilar approval.
  • To provide insights into the potential of biosimilars using tbo-filgrastim as a case study.

Main Methods:

  • Review of existing regulatory frameworks in the US and EU for biosimilar approval.
  • Analysis of clinical trial data requirements, including physiochemical, biologic, quality, and clinical endpoints.
  • Case study examination of tbo-filgrastim, a biosimilar marketed in Europe.

Main Results:

  • The US faces regulatory and legal hurdles in biosimilar adoption, unlike the EU's established pathway.
  • Key questions remain regarding the balance of analytic data versus clinical trials for approval.
  • The marketing and interchangeability of biosimilars present ongoing regulatory challenges.

Conclusions:

  • Clinicians and policymakers must actively engage in defining the role of biosimilars in oncology.
  • Understanding the nuances of biosimilar data requirements and regulatory pathways is essential for successful market integration.
  • The US introduction of agents like tbo-filgrastim will offer valuable insights into biosimilar utilization and impact.