The FDA has accepted the biologics license application for a proposed biosimilar for pegfilgrastim, which had been developed by Lupin Limited.
The FDA has accepted the biologics license application (BLA) for a proposed biosimilar for pegfilgrastim (Neulasta), which had been developed by Lupin Limited.1
The application is supported by similarity data gleaned from analytical, pharmacokinetic, pharmacodynamic, and immunogenicity studies.
“FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need,” Vinita Gupta, chief executive officer of Luptin Limited, stated in a press release. “This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment.”
In 2002, the FDA approved pegfilgrastim, a pegylated granulocyte colony-stimulating factor, for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies who were receiving myelosuppressive anticancer agents linked with a significant incidence of that adverse effect.2
The agent was examined in 3 double-blind, randomized, controlled trials. In Study 1, 157 patients were randomized to receive either pegfilgrastim at 6 mg on day 2 of each chemotherapy cycle or daily filgrastim at 5 mcg/kg/day beginning on day 2 of each chemotherapy cycle. Results showed that the mean days of cycle 1 severe neutropenia were 1.8 days in the investigative arm and 1.6 days in the control arm (difference in means 0.2; 95% CI, 0.2-0.6).
In Study 2, a total of 2,310 patients were randomized to pegfilgrastim at 100 mcg/kg on day 2 or daily filgrastim at 5 mcg/kg/day starting on day 2 of each chemotherapy cycle. Here, results showed that the mean days of cycle 1 severe neutropenia were 1.7 days in the investigative arm and 1.6 days in the control arm (difference in means 0.1; 95% CI, 0.2-0.4).
In Study 3, 928 patients were randomized to receive pegfilgrastim at 6 mg or placebo on day 2 of each chemotherapy cycle. The incidence of febrile neutropenia proved to be lower with pegfilgrastim vs placebo, at 1% vs 17%, respectively (P <.001). Moreover, the incidence of hospitalization and anti-infective treatment for febrile neutropenia both proved to be lower with pegfilgrastim vs placebo, at 1% vs 14%, respectively, and 2% vs 10%, respectively.
Previously, in June 2020, the FDA approved pegfilgrastim-apgf (Nyvepria), another biosimilar to pegfilgrastim), based on comprehensive supportive evidence showing that the product had a high degree of similarity to the reference product.3 The biosimilar was developed by Pfizer.
In 2019, the FDA gave the green light to another pegfilgrastim biosimilar, LA-EP2006 (pegfilgrastim-bmez; Ziextenzo), in the same indication; this product was developed by Sandoz.4 The decision was supported by analytical, preclinical, and clinical studies, including findings from the LA-EP06-104 trial. The latter trial compared the biosimilar with the US-sourced reference product, the biosimilar with the EU-sourced reference product, and the US-sourced reference product with the EU-sourced reference product. Data indicated that in all 3 comparisons, the pharmacokinetics and pharmacodynamics showed similarity, with no clinically meaningful differences in safety and immunogenicity reported between the groups.
In 2018, the FDA approved pegfilgrastim-cbqv (CHS-1701; Udenyca), another pegfilgrastim biosimilar developed by Coherus BioSciences, Inc., for patients with cancer receiving myelosuppressive chemotherapy.5 This decision was based on analytical similarity data between the reference product and the biosimilar, in addition to pharmacokinetic, pharmacodynamics, and immunogenicity studies of over 300 patients.