Related Experiment Video
Updated: Mar 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
Zarxio (Filgrastim-sndz): The First Biosimilar Approved by the FDA.
P & T : a Peer-Reviewed Journal for Formulary Management
|January 17, 2017
Summary
Zarxio (filgrastim-sndz) is a biosimilar used to treat severe chronic neutropenia. It helps manage low white blood cell counts in patients.
Area of Science:
- Hematology
- Pharmacology
- Immunology
Background:
- Severe chronic neutropenia is a condition characterized by abnormally low levels of neutrophils.
- Neutrophils are crucial white blood cells that fight infection.
- Managing neutropenia is essential for preventing serious infections.
Purpose of the Study:
- To evaluate Zarxio (filgrastim-sndz) as a biosimilar for treating severe chronic neutropenia.
- To assess the safety and efficacy of Zarxio in patients with this condition.
Main Methods:
- Clinical trials comparing Zarxio to the reference biologic.
- Assessment of neutrophil counts and infection rates.
- Monitoring of adverse events and immunogenicity.
Main Results:
- Zarxio demonstrated comparable efficacy to the reference biologic in increasing neutrophil counts.
- The safety profile of Zarxio was similar to the reference biologic.
- No significant differences in immunogenicity were observed.
Conclusions:
- Zarxio (filgrastim-sndz) is a safe and effective biosimilar for managing severe chronic neutropenia.
- It provides a valuable therapeutic option for patients requiring neutrophil support.
Related Concept Videos
01:28Drug Products: Biologics, Biosimilars and Interchangeables
328
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...
328
01:26FDA Approved Drugs: Changes to Approved Drugs
302
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,...
302
01:13Bioequivalence studies: Biowaivers
357
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...
357
01:02Prescription, Nonprescription and Orphan Drugs
1.3K
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
1.3K
01:24Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
675
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
675
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
58
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
58