Pegfilgrastim injection

Form: Injection

Strength: 6 mg per single-use syringe

Reference Brands: Neulasta, Pelgraz(US)

Category: Blood Disorder

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.