Neulasta Biosimilar Armlupeg FDA Approved to Prevent Infection

The U.S. Food and Drug Administration (FDA) has approved Armlupeg (pegfilgrastim-unne) 6 milligrams per 0.6 milliliter (mg/mL) injection for subcutaneous use in a single-dose prefilled syringe as a biosimilar to Neulasta (pegfilgrastim) 6 mg/0.6 mL injection, according to a news release from Lupin.

The drug is approved for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

“We are proud to achieve the FDA approval for our first biosimilar, [Armlupeg],” said Vinita Gupta, CEO, Lupin, in the news release. “This step marks a pivotal step in Lupin’s ongoing commitment to providing more affordable, accessible medicines to U.S. 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.”

The product will be produced at Lupin’s Biotech facility in Pune in India, which was reviewed by the FDA before approval.

“Our integrated biologic capabilities encompass the entire spectrum, from initial cell line development to upstream/downstream process optimization and clinical development,” Dr. Nilesh D. Gupta, managing director overseeing research, supply chain, manufacturing, quality and regulatory operations at Lupin, said in the news release.

He continues, “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.”

Dr. Cyrus Karkaria, president, biotechnology, Lupin, said in the news release, “We are pleased to have obtained approval for [Armlupeg]. This milestone demonstrates Lupin’s unwavering commitment to reducing barriers to treatment and empowering patients with greater choice and confidence in their healthcare journey.”

Lupin is a global pharmaceutical company that develops branded and generic medicines across major health conditions, with a focus on improving access to treatment and patient health outcomes.

Past Neulasta Biosimilar Approvals

January 4, 2024 – FDA Approves Udenyca Onbody Wearable Injector

Udenyca Onbody, an injector for Udenyca (pegfilgrastim-cbqv) that attaches to the patient’s body, was approved by the FDA. Udenyca is a biosimilar of Neulasta that is given the day after chemotherapy to prevent infection by stimulating the bone marrow to make white blood cells. Udenyca was originally approved in November 2018 to decrease infection, as manifested by febrile neutropenia, in patients undergoing myelosuppressive chemotherapy associated with a clinically significant increase in febrile neutropenia.

March 6, 2023 – FDA Approves Single-Dose Udenyca Autoinjector

A single-dose, prefilled autoinjector version of Udenyca (pegfilgrastim-cbqv) was approved by the FDA for patients with cancer undergoing myelosuppressive chemotherapy to potentially reduce the risk for infection. The drug is administered the day after chemotherapy to reduce febrile neutropenia — when a patient has a fever and low neutrophils, which increases the risk for infection.

June 1, 2022 – FDA Approves Fylnetra Neulasta Biosimilar

Fylnetra (pegfilgrastim-pbbk), a biosimilar to Neulasta, was approved by the FDA. Fylnetra promotes the growth of new and healthy white blood cells after chemotherapy to prevent neutropenia and is indicated for patients with non-myeloid malignancies receiving myelosuppressive cancer treatment associated with an increased risk for febrile neutropenia.

Reference

1. “Lupin Receives Approval from U.S. FDA for Biosimilar Armlupeg (pegfilgrastim-unne)” press release, Lupin Limited, December 1 2025.

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