Neulasta Biosimilar Armlupeg FDA Authorized to Stop An infection

The U.S. Meals and Drug Administration (FDA) has authorized 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, based on a information launch from Lupin.

The drug is authorized for sufferers with non-myeloid malignancies receiving myelosuppressive anti-cancer medication related to a clinically important incidence of febrile neutropenia and to extend survival in sufferers acutely uncovered to myelosuppressive doses of radiation.

“We’re proud to realize the FDA approval for our first biosimilar, [Armlupeg],” stated Vinita Gupta, CEO, Lupin, within the information launch. “This step marks a pivotal step in Lupin’s ongoing dedication to offering extra inexpensive, accessible medicines to U.S. sufferers. We look ahead to introducing a sturdy portfolio of biosimilars over the subsequent few years, which can assist enhance the standard of look after the communities and sufferers we serve.”

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

“Our built-in biologic capabilities embody your complete spectrum, from preliminary cell line growth to upstream/downstream course of optimization and scientific growth,” Dr. Nilesh D. Gupta, managing director overseeing analysis, provide chain, manufacturing, high quality and regulatory operations at Lupin, stated within the information launch.

He continues, “This, coupled with our state-of-the-art biologic facility that has now been authorized by each main regulatory physique, ensures that we ship biosimilars that meet the best world high quality requirements whereas attaining the size mandatory for world affordability.”

Dr. Cyrus Karkaria, president, biotechnology, Lupin, stated within the information launch, “We’re happy to have obtained approval for [Armlupeg]. This milestone demonstrates Lupin’s unwavering dedication to decreasing obstacles to therapy and empowering sufferers with larger selection and confidence of their healthcare journey.”

Lupin is a worldwide pharmaceutical firm that develops branded and generic medicines throughout main well being situations, with a concentrate on bettering entry to therapy and affected person well being outcomes.

Previous Neulasta Biosimilar Approvals

January 4, 2024 – FDA Approves Udenyca Onbody Wearable Injector

Udenyca Onbody, an injector for Udenyca (pegfilgrastim-cbqv) that attaches to the affected person’s physique, was authorized by the FDA. Udenyca is a biosimilar of Neulasta that’s given the day after chemotherapy to stop an infection by stimulating the bone marrow to make white blood cells. Udenyca was initially authorized in November 2018 to lower an infection, as manifested by febrile neutropenia, in sufferers present process myelosuppressive chemotherapy related to a clinically important enhance in febrile neutropenia.

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

A single-dose, prefilled autoinjector model of Udenyca (pegfilgrastim-cbqv) was authorized by the FDA for sufferers with most cancers present process myelosuppressive chemotherapy to probably scale back the danger for an infection. The drug is run the day after chemotherapy to cut back febrile neutropenia — when a affected person has a fever and low neutrophils, which will increase the danger for an infection.

June 1, 2022 – FDA Approves Fylnetra Neulasta Biosimilar

Fylnetra (pegfilgrastim-pbbk), a biosimilar to Neulasta, was authorized by the FDA. Fylnetra promotes the expansion of recent and wholesome white blood cells after chemotherapy to stop neutropenia and is indicated for sufferers with non-myeloid malignancies receiving myelosuppressive most cancers therapy related to an elevated threat for febrile neutropenia.

Reference

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

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