Pegfilgrastim Injection Generics - Manufacturers & Suppliers
Neulasta, Pelgraz(US)
| Product/Composition:- | Pegfilgrastim injection |
|---|---|
| Strength:- | 6 mg per single-use syringe |
| Form:- | Injection |
| Reference Brands:- | Neulasta, Pelgraz(US) |
| MOQ | As per the manufacturer batch size |
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Pegfilgrastim stimulates the production of neutrophils by binding to G-CSF receptors, reducing the risk of infection during chemotherapy-induced neutropenia. Its benefits include rapid neutrophil recovery, decreased infection rates, fewer hospitalizations, and improved treatment safety, enabling patients to continue chemotherapy effectively with lower complication risks.
Pegfilgrastim injection, marketed as Neulasta and biosimilars like Pelgraz, is approved in the US by the FDA and in the EU via EMA for preventing chemotherapy-induced neutropenia. Regulatory approval requires a comprehensive dossier including biosimilarity data, clinical efficacy, safety, manufacturing quality, and pharmacovigilance plans. In the US, FDA review involves detailed assessment of the biosimilar complex, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and successful market access strategies, visit PharmaTradz. Ensuring compliance with regional regulations is essential for the safe, effective, and timely approval of pegfilgrastim injection worldwide, supporting patient safety during cancer chemotherapy.