Fda Accepts Application for Pegfilgrastim Biosimilar

The Fda has acknowledged the biologics license software (BLA) for a proposed biosimilar for pegfilgrastim

The Fda has acknowledged the biologics license software (BLA) for a proposed biosimilar for pegfilgrastim (Neulasta), which experienced been developed by Lupin Minimal.1

The application is supported by similarity facts gleaned from analytical, pharmacokinetic, pharmacodynamic, and immunogenicity research.

“FDA’s acceptance of our BLA is a sizeable achievement and demonstrates our motivation to providing items which increase entry in spots of considerable health-related need,” Vinita Gupta, main government officer of Luptin Limited, stated in a push launch. “This BLA expands our oncology portfolio, an spot of expanding concentrate for Lupin. We glimpse ahead to the opportunity to bring affordable biologic alternatives to individuals and raising obtain to this significant procedure.”

In 2002, the Fda accepted pegfilgrastim, a pegylated granulocyte colony-stimulating element, for lowering the incidence of an infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies who have been acquiring myelosuppressive anticancer brokers joined with a significant incidence of that adverse influence.2

The agent was examined in 3 double-blind, randomized, controlled trials. In Examine 1, 157 people have been randomized to obtain either pegfilgrastim at 6 mg on day 2 of each individual chemotherapy cycle or day-to-day filgrastim at 5 mcg/kg/working day beginning on working day 2 of each chemotherapy cycle. Benefits confirmed that the suggest days of cycle 1 extreme neutropenia ended up 1.8 times in the investigative arm and 1.6 days in the manage arm (variance in implies .2 95% CI, .2-.6).

In Examine 2, a whole of 2,310 patients were being randomized to pegfilgrastim at 100 mcg/kg on day 2 or each day filgrastim at 5 mcg/kg/day starting off on working day 2 of every chemotherapy cycle. Right here, success confirmed that the necessarily mean days of cycle 1 extreme neutropenia had been 1.7 times in the investigative arm and 1.6 days in the regulate arm (distinction in implies .1 95% CI, .2-.4).

In Study 3, 928 individuals have been randomized to acquire pegfilgrastim at 6 mg or placebo on day 2 of each chemotherapy cycle. The incidence of febrile neutropenia proved to be reduced 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.


  1. Lupin announces US FDA acceptance for pegfilgrastim biosimilar application. News release. June 2, 2021. Accessed June 3, 2021. https://bit.ly/3w2F8vG
  2. Neulasta. Prescribing Information. Amgen Inc 2002. Accessed June 3, 2021. https://bit.ly/3phhB7Y
  3. FDA approves Pfizer’s oncology supportive care biosimilar, Nyvepria (pegfilgrastim-apgf). News release. Pfizer Inc. June 11, 2020. Accessed June 3, 2021. https://bit.ly/3ceFxDw
  4. Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez). News release. Sandoz. November 5, 2019. Accessed June 3, 2021. https://bit.ly/2PP20Nh
  5. Coherus Biosciences, Inc. US FDA approves UDENYCA (pegfilgrastim-cbqv). News release. Coherus BioSciences, Inc. November 2, 2018. Accessed June 3, 2021. https://bit.ly/2Rxyt8c

This article was originally published on OncLive.com as, “FDA Accepts Application for Lupin Limited’s Pegfilgrastim Biosimilar.”

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