Related Experiment Video
Updated: Oct 15, 2025
07:25
In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
17.9K
Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?
Eduardo Mysler1, Valderilio Feijó Azevedo2, Silvio Danese3
1Organización Médica de Investigación, Buenos Aires, Argentina. E.mysler@omiargentina.com.ar.
Drugs
|October 27, 2021
Summary
Clinicians can switch patients between biosimilars, but this cross-switching lacks clinical trial data. This review consolidates real-world evidence to support informed decision-making for biosimilar transitions.
Area of Science:
- Rheumatology
- Immunology
- Pharmacology
Background:
- Clinicians increasingly prescribe biosimilars for inflammatory diseases.
- Switching from reference biologics to biosimilars is supported by safety and efficacy data.
- Switching between different biosimilars (cross-switching) lacks direct clinical trial evidence.
Purpose of the Study:
- To review real-world evidence on biosimilar-to-biosimilar cross-switching.
- To provide guidance for clinicians making cross-switching decisions in the absence of clinical trials.
- To consolidate information on biosimilar cross-switching for informed clinical practice.
Main Methods:
- Review of emerging real-world data on biosimilar cross-switching.
- Integration of scientific understanding of biosimilarity.
- Case-by-case clinical evaluation framework.
Main Results:
- Cross-switching between biosimilars can occur for various clinical and practical reasons.
- Real-world evidence is emerging to inform safety and efficacy of cross-switching.
- No current regulatory guidelines specifically address biosimilar-to-biosimilar switching.
Conclusions:
- Clinicians must evaluate cross-switching decisions using available real-world data and patient-specific factors.
- Further research and guidelines are needed to address biosimilar-to-biosimilar transitions.
- This review aims to support educated clinical decision-making regarding biosimilar cross-switching.
Related Concept Videos
01:28Drug Products: Biologics, Biosimilars and Interchangeables
17
Body: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...
17
01:13Bioequivalence studies: Biowaivers
20
Body: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...
20
01:16Bioequivalence: Overview
1.3K
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,...
1.3K
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
15
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...
15
01:22Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence
23
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...
23
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
23
Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
23