Related Experiment Video
Updated: May 26, 2026
07:25
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Biosimilars
1National Institutes of Health, NIDDK, USA. malozowskis@extra.niddk.nih.gov
Arquivos Brasileiros De Endocrinologia E Metabologia
|January 6, 2012
Summary
Regulatory policies for biologics are evolving globally, requiring adaptable frameworks. Agencies, industry, and the public must collaborate for realistic expectations and efficient drug approval processes.
Area of Science:
- Biopharmaceutical regulatory affairs
- Global health policy
Background:
- International regulatory policies for biologics exhibit common themes but also significant divergences.
- Existing and developing policies face challenges in accommodating diverse biologics and emerging scientific advancements.
Purpose of the Study:
- To analyze the dynamic nature of global regulatory policies for biologics.
- To identify areas for improved collaboration between regulatory agencies, the pharmaceutical industry, and the public.
Main Methods:
- Review of current international regulatory landscapes for biologics.
- Analysis of policy adaptability to novel and complex biological products.
Main Results:
- Policies are in flux and not universally applicable to all biologics.
- Accelerated approval pathways should be considered for less complex compounds.
- A need exists for greater transparency from regulatory agencies and social responsibility from industry.
Conclusions:
- Regulatory frameworks for biologics require continuous adaptation to scientific progress.
- Enhanced collaboration and realistic public expectations are crucial for effective biologic development and approval.
Related Concept Videos
01:28Drug 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...
01:16Bioequivalence: 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,...
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
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 indication due to...
01:26Pharmaceutical 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.
01:22Pharmaceutical 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...
01:13Bioequivalence 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...