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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Bioequivalence: Overview01:16

Bioequivalence: Overview

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,...
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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...
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Are biosimilars really generics?

Anoop Misra1

  • 1Fortis Flt. Lt. Rajan Dhall Hospital, Department of Diabetes and Metabolic Diseases, Vasant Kunj, New Delhi 110070, India. anoopmisra@metabolicresearchindia.com

Expert Opinion on Biological Therapy
|February 12, 2010
PubMed
Summary
This summary is machine-generated.

Biosimilar medicines are similar to reference biologics but differ significantly from generic drugs due to complex manufacturing. Regulatory oversight is crucial to ensure safety and efficacy, preventing automatic substitution.

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Area of Science:

  • Biotechnology
  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • Over 150 biopharmaceutical products have been marketed globally.
  • Many originator biologic products are nearing patent expiry.
  • This has led to increased development and interest in biosimilar medicines.

Purpose of the Study:

  • To review the key differences between biosimilars and generic drugs.
  • To highlight the unique manufacturing and regulatory considerations for biosimilars.

Main Methods:

  • Literature review focusing on biosimilar development and regulation.
  • Comparative analysis of biosimilar and generic drug characteristics.

Main Results:

  • Biosimilars share similar active substances with reference biologics but differ in size, complexity, and manufacturing processes.
  • Biopharmaceutical manufacturing involves intricate, proprietary steps with potential safety and efficacy implications.
  • Biosimilars are distinct from generics of small-molecule drugs.

Conclusions:

  • Biosimilars require distinct regulatory pathways separate from generics.
  • Regulations should prevent automatic substitution of biosimilars for reference products.
  • Ensuring appropriate use is critical for patient safety and therapeutic outcomes.