FDA Approves Armlupeg – New Pegfilgrastim Biosimilar

The U.S. Food and Drug Administration has approved Armlupeg™ (pegfilgrastim‑unne) as a biosimilar to Neulasta® (pegfilgrastim) for decreasing the incidence of infection manifested by febrile neutropenia in patients with non‑myeloid malignancies receiving myelosuppressive chemotherapy, and for increasing survival after acute exposure to myelosuppressive radiation. This approval adds another pegfilgrastim biosimilar to the U.S. market and is notable because pegfilgrastim remains a standard of care for prophylaxis of chemotherapy‑induced neutropenia.

Mechanism, formulation, and clinical role

Pegfilgrastim is a pegylated granulocyte colony‑stimulating factor (G‑CSF) that stimulates neutrophil production in bone marrow, reducing the duration and severity of neutropenia after cytotoxic chemotherapy. Armlupeg is supplied as a 6 mg/0.6 mL single‑dose prefilled syringe for subcutaneous injection, matching the common clinical dosing format for pegfilgrastim products. Use of biosimilar pegfilgrastim agents aims to preserve clinical outcomes while increasing competition and potentially lowering costs.

Quick comparison: Armlupeg versus reference pegfilgrastim

Attribute	Armlupeg (pegfilgrastim‑unne)	Neulasta (pegfilgrastim)
Indication	Febrile neutropenia prophylaxis; radiation survival	Febrile neutropenia prophylaxis; radiation survival
Dose / presentation	6 mg / 0.6 mL prefilled syringe	6 mg / 0.6 mL prefilled syringe
Regulatory status (US)	FDA‑approved biosimilar (Dec 2025)	Reference biologic (approved Jan 2002)
Manufacturing	Produced at Lupin’s Pune biotech facility	Manufactured by reference sponsor

Evidence of similarity and regulatory review

Regulatory summaries and expert commentary indicate that the approval was supported by analytical, nonclinical, and clinical data demonstrating a high degree of similarity with no clinically meaningful differences in safety, purity, or potency. The FDA also reviewed the manufacturing facility as part of its evaluation, a critical step for biologics because process controls and facility standards directly affect product quality and consistency.

Clinical and health‑system significance

• Patient access and choice. Additional biosimilars increase therapeutic options for clinicians and patients, which can be important when supply constraints or device preferences (e.g., on‑body injectors vs prefilled syringes) influence care.
• Economic impact. Pegfilgrastim had estimated U.S. annual sales in the low‑billion dollar range; biosimilar competition historically reduces net prices and payer costs, potentially improving affordability for health systems and patients.
• Supply resilience. Multiple approved manufacturers reduce single‑source risk for an essential supportive‑care biologic used across oncology practices.

Key Takeaway

The FDA approval of Armlupeg (pegfilgrastim‑unne) represents a scientifically grounded expansion of pegfilgrastim biosimilars in the U.S., supported by analytical and clinical comparability data and regulatory inspection of manufacturing. This approval has the potential to improve access, strengthen supply chains, and exert downward pressure on costs for a widely used supportive oncology therapy.

References (3) 

1. Cure Today — Neulasta Biosimilar Armlupeg FDA Approved to Prevent Infection https://www.curetoday.com/view/neulasta-biosimilar-armlupeg-fda-approved-to-prevent-infection 
2. Lupin — Lupin Receives Approval from U.S. FDA for Biosimilar Armlupeg (Pegfilgrastim‑unne) https://www.lupin.com/lupin-receives-approval-from-u-s-fda-for-biosimilar-armlupeg-pegfilgrastim-unne/ 
3. MPR / EMPR — Neulasta Biosimilar Armlupeg Approved by FDA https://www.empr.com/news/neulasta-biosimilar-armlupeg-approved-by-fda/