Sandoz announces new Phase I data showing proposed biosimilar pegfilgrastim matches reference medicine.
Sandoz, a division of Novartis, confirmed that its biosimilar pegfilgrastim in a Phase I study matches the Amgen Inc. reference biologic Neulasta*1 in terms of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity profiles1.
Neulasta is used to fight infection in cancer patients. According to the Amgen’s Neulasta website, “In a key study of 928 patients with breast cancer, when given once every chemotheraphy cycle, Neulasta helped protect against the risk of infection,” adding that 17 percent of patients got infections when not treated with Neulasta, while only 1 percent got infections when treated with Neulasta.
Data from the study, conducted in healthy volunteers, were presented last week during the 2017 San Antonio Breast Cancer Symposium.
“These findings add to the totality of evidence supporting our proposed biosimilar pegfilgrastim,” Mark Levick, M.D. Ph.D., global head of development, biopharmaceuticals at Sandoz, said.
The Sandoz biosimilar to pegfilgrastim, a long-acting formulation of filgrastim (granulocyte colony-stimulating factor [G-CSF])2, is currently under review by the European Medicines Agency (EMA) for use in the same indication as the reference biologic, according to Sandoz.
Study participants were randomized to receive a single 6 mg subcutaneous injection of biosimilar pegfilgrastim or reference medicine on Day 01. After dosing, study participants underwent a 4-week assessment period followed by an 8-week washout period before crossing over to receive the other medicine, and were assessed for a further 4-weeks1.
The results demonstrated that Sandoz proposed biosimilar pegfilgrastim matched the reference medicine in the PK and PD comparisons as primary endpoints, in terms of absolute neutrophil count (maximum effect attributed to study medication) (95 percent CI: [0.97, 1.02]) and maximum serum concentration of study medication after administration (90 percent CI: [1.03, 1.19])1.
Secondary endpoints of safety and immunogenicity were comparable between both groups1, Sandoz reported.
*Neulasta® is a registered trademark of Amgen Inc.
1 Nakov, R. et al. Proposed biosimilar pegfilgrastim LA-EP2006 shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects. Poster session 3. 2017 San Antonio Breast Cancer Symposium.
2 European Medicines Agency. Neulasta: EPAR – Product Information. Available at: https://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000420/WC500025945.pdf, Last Accessed: November 2017.
Filed Under: Drug Discovery