Filgrastim Injection (Subcutaneous and IV)

Form: Injection (Subcutaneous and IV)

Strength: 300 million IU

Reference Brands: Neupogen, Granix, Zarxio(US)

Category: Blood Disorder

Filgrastim injection, marketed as Neupogen and biosimilars like Zarxio, is approved in both the US by the FDA and in the EU via EMA for neutropenia treatment. Regulatory approval requires a comprehensive dossier including clinical trial data, biosimilarity evidence, manufacturing quality, safety, and pharmacovigilance plans. In the US, FDA review involves detailed biosimilar and safety assessments, while the EMA ensures strict compliance with regional standards. For guidance on dossier preparation, regulatory strategies, and market access, visit PharmaTradz. Ensuring compliance with regional regulations is essential for the safe, effective, and timely approval of filgrastim injection worldwide, supporting improved patient outcomes in chemotherapy and bone marrow transplantation.