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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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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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Drug Regulation01:25

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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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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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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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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...
366
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

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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

Bioequivalence of Drugs: Drugs with Multiple Indications

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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 Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilars: The US Regulatory Framework.

Leah A Christl1, Janet Woodcock1, Steven Kozlowski1

  • 1US Food and Drug Administration, Silver Spring, Maryland 20993; email: Leah.Christl@fda.hhs.gov , Janet.Woodcock@fda.hhs.gov , Steven.Kozlowski@fda.hhs.gov.

Annual Review of Medicine
|November 5, 2016
PubMed
Summary
This summary is machine-generated.

The US biosimilars program uses analytical data to ensure product similarity. This robust scientific approach, integrating various data types, supports the safe introduction of new biosimilar medicines.

Keywords:
biologicbiosimilarinterchangeable

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Area of Science:

  • Biopharmaceutical regulation
  • Drug development
  • Analytical chemistry

Background:

  • The Biologics Price Competition and Innovation Act of 2009 created an abbreviated pathway for biosimilar and interchangeable biological products in the US.
  • The US Food and Drug Administration (FDA) oversees the development and licensing of these products.

Purpose of the Study:

  • To outline the regulatory framework and technical requirements for the US biosimilars program.
  • To explain the "totality of the evidence" approach used to demonstrate biosimilarity.
  • To discuss the integration of analytical, pharmacological, and clinical data in biosimilar assessment.

Main Methods:

  • A stepwise approach heavily reliant on analytical methods.
  • Integration of analytical, pharmacological, and clinical data.
  • Demonstration of biosimilarity to a reference product through a "totality of the evidence" assessment.

Main Results:

  • A robust scientific program has been established for biosimilar development and licensing.
  • Three biosimilars have been licensed, with a fourth approved post-writing.
  • Numerous development programs are underway, indicating future market growth.

Conclusions:

  • The US biosimilars program utilizes a comprehensive, evidence-based approach to ensure product safety and efficacy.
  • Despite remaining questions, the program is well-established and poised for expansion.
  • Clinicians can anticipate a growing number of biosimilar options in the US market.