Related Experiment Video
Updated: Feb 8, 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
18.3K
The complexities of biosimilars and the regulatory approval process
1Center for Pharmacy Practice Excellence, Vizient, Irving, TX.
The American Journal of Managed Care
|June 30, 2018
Summary
Biosimilars offer competition for biologics, similar to generics, to lower healthcare costs. Regulatory approval ensures they are highly similar to reference products in safety and efficacy.
Area of Science:
- Pharmaceutical Science
- Health Economics
- Regulatory Science
Background:
- Biosimilars were created by the Biologics Price Competition and Innovation Act to foster competition for biologics.
- This mirrors the generic drug model, which has supported access and innovation for over 30 years.
Purpose of the Study:
- To enhance understanding of biosimilars, covering clinical, manufacturing, and cost aspects.
- To support clinician acceptance and advance biosimilar science.
Main Methods:
- Review of clinical, scientific, and regulatory factors influencing biosimilar adoption.
- Analysis of manufacturing considerations and cost implications.
Main Results:
- Biosimilars are approved by the FDA upon demonstration of high similarity to reference biologics without clinically meaningful differences.
- Increasing adoption is expected due to healthcare cost concerns and stakeholder policies.
Conclusions:
- Understanding the evolving clinical, scientific, and regulatory landscape is crucial for biosimilar advancement.
- Biosimilars represent a significant opportunity to reduce biologic drug expenses, particularly in oncology.
Related Concept Videos
01:26FDA Approved Drugs: Changes to Approved Drugs
273
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
273
02:02Cis-regulatory Sequences
11.9K
Cis-regulatory sequences are short fragments of non-coding DNA that are present on the same chromosomes as the genes that they regulate. These fragments serve as binding sites for transcriptional regulators, proteins that are responsible for controlling gene transcription and differential gene expression across cell types in eukaryotes. Cis-regulatory sequences can be close to the gene of interest or thousands of bases away in the DNA sequence; however, those sequences that are further away are...
11.9K
02:02Cis-regulatory Sequences
4.2K
4.2K
01:28Drug Products: Biologics, Biosimilars and Interchangeables
279
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...
279
02:41Protein Complex Assembly
16.8K
Proteins can form homomeric complexes with another unit of the same protein or heteromeric complexes with different types. Most protein complexes self-assemble spontaneously via ordered pathways, while some proteins need assembly factors that guide their proper assembly. Despite the crowded intracellular environment, proteins usually interact with their correct partners and form functional complexes.
Many viruses self-assemble into a fully functional unit using the infected host cell to...
Many viruses self-assemble into a fully functional unit using the infected host cell to...
16.8K
01:28Global Regulatory Systems
696
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
696