Late November 2025 marked a milestone in cancer care when the U.S. Food and Drug Administration approved Lupin Limited’s Armlupeg (pegfilgrastim-unne) for use in patients undergoing chemotherapy or exposed to radiation.
Armlupeg is a “biosimilar” to the well-known drug Neulasta (pegfilgrastim). Like Neulasta, it helps stimulate the bone marrow to produce more white blood cells, a key defense against infections when the immune system is suppressed by cancer treatment.
The drug comes as a single-dose, prefilled syringe for subcutaneous injection. Its main role is to reduce the risk of febrile neutropenia, a dangerous drop in white blood cells accompanied by fever and infection, commonly seen in non-myeloid cancer patients receiving myelosuppressive chemotherapy. It’s also approved for improving survival in people exposed to high doses of radiation that suppress bone marrow.
Why is this approval important?
First, it offers patients and doctors more treatment options, potentially increasing access while putting downward pressure on costs. For the company behind it, it’s a major step in their push to supply affordable biologics globally.
MBH/PS