
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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