Lupin Gains USFDA Approval for New Cancer Biosimilar

Lupin gets USFDA nod for biosimilar drug

Lupin gets USFDA approval for Armlupeg, a biosimilar to Neulasta, to treat neutropenia in cancer patients. The drug will be manufactured at Lupins Pune facility. Armlupeg aims to reduce infection risk from chemotherapy, and Lupin plans to expand its US biosimilar portfolio. The US market for Pegfilgrastim is worth over $1.29 billion annually.

Lupin Gains USFDA Approval for New Cancer Biosimilar

Lupin secures USFDA approval for Armlupeg, a biosimilar indicated for treating neutropenia in cancer patients. The drug, produced at Lupin’s Pune facility, offers a cost-effective alternative to Neulasta. Lupin aims to expand its biosimilar portfolio, enhancing healthcare accessibility in the US market.

Neulasta Biosimilar Armlupeg FDA Approved to Prevent Infection

The FDA approved Armlupeg as a biosimilar to Neulasta to reduce infection risk in people receiving chemotherapy and those exposed to radiation.

US FDA approves Lupin’s Armlupeg injection

Lupin has FDA approval for Armlupeg 6mg/0.6ml injection in a single-dose prefilled syringe, for subcutaneous use, as a biosimilar to Neulasta.

Lupin’s biosimilar Armlupeg gains U.S.FDA approval

Lupin today announced that the United States Food and Drug Administration (U.S. FDA) has approved Armlupeg (pegfilgrastim-unne) 6 mg/0.6 mL injection for subcutaneous use in a single-dose prefilled syringe, as biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection. The product will be manufactured at Lupin’s Biotech facility in Pune, which was inspected by the U.S. FDA prior to approval.  Armlupeg is indicated for:   Decrease the incidenc…

Lupin shares in news as Armlupeg Biosimilar gets USFDA nod, more details - BusinessToday

Lupin has received USFDA approval for its biosimilar Armlupeg (pegfilgrastim-unne) injection, to be manufactured at its Pune facility.