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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

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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

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

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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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Biosimilar safety considerations in clinical practice.

Edwin Choy1, Ira Allen Jacobs2

  • 1Director of Sarcoma Research, Division of Hematology Oncology, Massachusetts General Hospital, Boston, MA.

Seminars in Oncology
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PubMed
Summary
This summary is machine-generated.

Biosimilars offer accessible alternatives to biologics as patents expire. Rigorous evaluation ensures biosimilar safety and efficacy are comparable to original biologics, benefiting cancer treatment.

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Area of Science:

  • Oncology
  • Pharmacology
  • Biotechnology

Background:

  • Biologics are crucial cancer treatments, but patent expirations are paving the way for biosimilar development.
  • Biosimilars are complex biological products, distinct from generic small-molecule drugs, requiring rigorous analytical and clinical evaluation.
  • Regulatory agencies mandate high similarity to the reference biologic, with any differences clinically justified.

Purpose of the Study:

  • To provide context on safety considerations in biosimilar development, approval, and clinical use.
  • To inform oncologists about safety aspects when prescribing biosimilars.
  • To review safety data from regions where biosimilars are already utilized.

Main Methods:

  • Review of regulatory guidelines for biosimilar approval.
  • Analysis of clinical and analytical data requirements for biosimilar authorization.
  • Examination of post-market safety surveillance data from various regions.

Main Results:

  • Biosimilars undergo stringent regulatory review to ensure high similarity to reference biologics.
  • Demonstrated analytical and clinical comparability is essential for biosimilar approval.
  • Real-world data from regions with established biosimilar markets inform safety profiles.

Conclusions:

  • Biosimilars represent a significant advancement in making complex biologic therapies more accessible.
  • Regulatory frameworks ensure that biosimilars meet high standards for safety and efficacy.
  • Ongoing monitoring and data review are crucial for understanding and managing biosimilar safety in clinical practice.