Overview
- Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL is approved as a single-dose prefilled syringe for subcutaneous use.
- The product will be manufactured at Lupin’s biotech facility in Pune, which the FDA inspected before approval.
- Indications include reducing febrile neutropenia in patients with non-myeloid cancers receiving myelosuppressive therapy.
- The drug is also cleared to increase survival after acute exposure to myelosuppressive levels of radiation.
- CEO Vinita Gupta cast the decision as a step toward a broader U.S. biosimilars portfolio, with modest share moves reported following the announcement.