Sandoz’s biosimilar of Neulasta, or pegfilgrastim, matched the reference product in a clinical trial, according to the company. Researchers found equivalence in pharmacokinetics, pharmacodynamics, immunogenicity and safety, Sandoz reported.
Sandoz recently announced that a proposed biosimilar of pegfilgrastim (Neulasta) matches the reference biologic in terms of pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity, according to a press release.
Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor), which is used to increase production of white blood cells following cancer treatment.
Included in the study were healthy patients who were randomized to receive a single 6-mg subcutaneous injection of the biosimilar or reference product.
After dosing, patients were assessed for 4 weeks and then underwent an 8-week washout period before receiving the other therapy. Patients were assessed for 4 weeks while on the new therapy, according to the release.
The investigators found that the proposed biosimilar matched the reference product in PK and PD in terms of absolute neutrophil count and maximum serum concentration, which were the primary endpoints, according to Sandoz. Secondary endpoints included safety and immunogenicity, which they were comparable between treatments.
Currently, the pegfilgrastim biosimilar is under review by the European Medicines Agency for the same indication as the reference product, according to Sandoz.
“At Sandoz, we are committed to developing high-quality biosimilar and generic medicines that provide the oncology community with treatment options to help manage their patients,” said Mark Levick, MD PhD, global head of development, Biopharmaceuticals, Sandoz, “And it starts with following the science. These findings add to the totality of evidence supporting our proposed biosimilar pegfilgrastim.”