FDA Approves Pegfilgrastim-unne for Nonmyeloid Cancers, Febrile Neutropenia

The FDA has approved pegfilgrastim-unne (Armlupeg) for the treatment of patients with nonmyeloid cancers undergoing treatment with myelosuppressive anticancer drugs linked to a significant chance of developing febrile neutropenia.¹ 

Pegfilgrastim-unne has been approved as a 6 mg/0.6 ml injection in a single-dose prefilled syringe for subcutaneous use as a biosimilar to pegfilgrastim (Neulasta). Pegfilgrastim is used to stimulate the bone marrow and promote the growth of white blood cells. This is used to decrease infection by treating neutropenia, which is often caused by chemotherapy.

The agent is indicated to improve survival rates in patients who have been acutely exposed to myelosuppressive levels of radiation. 

“We are proud to achieve the FDA approval for our first biosimilar, [p]egfilgrastim,” said Vinita Gupta, CEO of Lupin, in a news release. “This step marks a pivotal step in Lupin’s ongoing commitment to providing more affordable, accessible medicines to US patients. We look forward to introducing a robust portfolio of biosimilars over the next few years, which will help improve the quality of care for the communities and patients we serve.”

History of Pegfilgrastim

In June 2021, the FDA accepted the biologics license application for peg-filgrastim, a proposed pegfilgrastim biosimilar, for the treatment of patients with breast cancer. 

A randomized phase 4 study (NCT03511378)² completed in January 2019 examined the efficacy of peg-filgrastim compared with pegfilgrastim as adjunct to chemotherapy in patients with breast cancer. The primary end point of the study was the comparison of cumulative incidence of anti-pegfilgrastim antibodies at the end of the fourth cycle (day 84). The secondary end points included the comparison of cumulative incidence of anti-peg antibodies between treatment groups at the end of the fourth cycle, and the comparison of incidents of anti-pegfilgrastim antibodies to pegfilgrastim between treatment groups on days 10, 21, 42, 63, and 84. 

In June 2020, the FDA approved pegfilgrastim-apgf (Nyvepria), a biosimilar of pegfilgrastim, for the treatment of patients with nonmyeloid malignancies who are not receiving myelosuppressive anticancer agents that have a clinical association with significant incidence of febrile neutropenia.

“Our integrated biologic capabilities encompass the entire spectrum, from initial cell line development to upstream/downstream process optimization and clinical development,” said Nilesh Gupta, MD, of Lupin, in a news release.¹ “This, coupled with our state-of-the-art biologic facility that has now been approved by every major regulatory body, ensures that we deliver biosimilars that meet the highest global quality standards while achieving the scale necessary for global affordability.” 

REFERENCES

1.US FDA approves Lupin’s Armlupeg injection. News release. Pharmaceutical Technology. Published and accessed December 1, 2025. https://tinyurl.com/y7vvv5kx 

2.Immunogenicity assessment of peg-filgrastim vs. Neulasta as adjunct to chemotherapy in patients with breast cancer. ClinicalTrials.gov. Updated June 15, 2021. Accessed December 1, 2025. https://clinicaltrials.gov/study/NCT03511378