Pegfilgrastim biosimilar - Lupin
Alternative Names: Armlupeg; Lupifil-P; Pegfilgrastim - LupinLatest Information Update: 28 Aug 2024
At a glance
- Originator Lupin
- Class Antineoplastics; Chemoprotectants; Granulocyte colony-stimulating factors; Polyethylene glycols; Radioprotectives; Recombinant proteins
- Mechanism of Action Granulocyte colony stimulating factor replacements; Granulocyte colony-stimulating factor receptor agonists
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Marketed Febrile neutropenia
Most Recent Events
- 23 Aug 2024 Registered for Febrile neutropenia (Adjunctive treatment, In the elderly, Prevention, In adults) in Canada (SC)
- 01 Feb 2022 Pegfilgrastim biosimilar licensed to Axantia in Saudi Arabia, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria
- 02 Jun 2021 The US FDA accepts the Biologics License Application (BLA) for pegfilgrastim