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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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Bioequivalence: Overview01:16

Bioequivalence: Overview

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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 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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Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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 Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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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: potential implications for clinicians.

Misty G Eleryan1, Sophia Akhiyat2, Monica Rengifo-Pardo1

  • 1Department of Dermatology, The George Washington Medical Faculty Associates, Washington, DC, USA.

Clinical, Cosmetic and Investigational Dermatology
|July 7, 2016
PubMed
Summary
This summary is machine-generated.

Biosimilars, highly similar biologic drugs, offer potential cost savings and improved patient access. Unlike generics, they require extensive studies and regulatory oversight due to not being exact copies.

Keywords:
biocopiesbiologicsbiomimicsbiopharmaceuticalsimmunogenicityinterchangeability

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Area of Science:

  • Pharmaceutical Science
  • Biotechnology
  • Regulatory Affairs

Background:

  • Patent expirations for biologics are driving the development of biosimilars.
  • Biosimilars are highly similar but not identical to reference biologic products.
  • Concerns regarding safety and efficacy necessitate distinct regulatory pathways.

Purpose of the Study:

  • To discuss the emergence and characteristics of biosimilars.
  • To highlight the regulatory landscape and approval processes for biosimilars.
  • To address the potential impact of biosimilars on healthcare costs and patient access.

Main Methods:

  • Review of regulatory guidelines and scientific literature on biosimilars.
  • Comparison of biosimilar and generic drug development and approval processes.
  • Analysis of the European and US regulatory approaches to biosimilars.

Main Results:

  • Biosimilars require extensive nonclinical and clinical bioequivalence studies.
  • Separate regulatory pathways, including post-marketing surveillance, are established for biosimilars.
  • Europe has a more advanced clinical integration of biosimilars compared to the US.

Conclusions:

  • Biosimilars represent a new class of therapeutic agents distinct from generics.
  • Rigorous evaluation is essential for ensuring the safety and efficacy of biosimilars.
  • Increased physician familiarity with biosimilar indications is needed for wider adoption.