FDA Considering Approval of New Pegfilgrastim Biosimilar for Breast Cancer


The FDA has accepted the biologics license application for peg-filgrastim, a proposed pegfilgrastim biosimilar.

The FDA has accepted the biologics license application (BLA) for peg-filgrastim, a proposed pegfilgrastim (Neulasta) biosimilar, according to a press release by the developer, Lupin Limited.1

“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. This BLA expands our oncology portfolio, an area of increasing focus for Lupin,” said Vinita Gupta, chief executive officer of Lupin, in a press release. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment.”

Pegfilgrastim is used to stimulate the bone marrow and promote the growth of white blood cells. This is used to decrease infection by treating neutropenia, which is often caused by chemotherapy. It is produced by covalently bonding a 20kD monomethoxypolyethylene glycol molecule to the N-terminal methionyl residue of filgrastim.2

The BLA was supported by similarity data from several analytical, pharmacokinetic, pharmacodynamic, and immunogenicity studies.

One such study looked at the efficacy of peg-filgrastim compared with pegfilgrastim as adjunct to chemotherapy in patients with breast cancer (NCT03511378). The randomized phase 4 study enrolled about 138 patients and was completed in January 2019. The study had a primary end point of the comparison of cumulative incidence of anti-pegfilgrastim antibodies at the end of cycle 4 (Day 84). Secondary end points included the comparison of cumulative incidence of anti-peg antibodies between treatment groups at the end of cycle 4, and the comparison of incidents of anti-pegfilgrastim antibodies to pegfilgrastim between treatment groups on day 10, day 21, day 42, day 63, and day 84.

During the study, patients were randomized into 1 of 2 arms. In arm 1, patients received pegfilgrastim and in arm 2, patients received Neulasta.

In order to participate, patients must be female and 18 years of age or older, have a proven diagnosis of breast cancer and are eligible for neoadjuvant or adjuvant chemotherapy, must be planning to receive chemotherapy, have not received any hematopoietic growth factors, have an ECOG performance status of 2 or less, have a life expectancy of 6 months or greater, and no evidence of hemorrhage. Male patients, patients who are hypersensitivity to any study drug or its components, patients weighing less than 45 kg, or any patient with myeloid malignancies are note eligible to participate. 

Lupin’s pegfilgrastim biosimilar is not the first to hit the market. In June of 2020, Pfizer received FDA approval for pegfilgrastim-apgf. It is intended for use in patients with non-myeloid malignancies not are receiving myelosuppressive anti-cancer agents that have a clinical association with significant incidence of febrile neutropenia.

1.Lupin announces U.S. FDA acceptance for Pegfilgrastim biosimilar application. News release. Lupin. June 2, 2021. Accessed June 3, 2021. https://bit.ly/3yW49uy.
2.NEULASTA. RxList. Accessed June 3, 2021. https://bit.ly/3uMS3AH.

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