Phase 1 Data Show Sandoz's Proposed Pegfilgrastim Biosimilar Matches Neulasta's Profile

Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects.

The data were presented at the San Antonio Breast Cancer Symposium,¹ held December 5 to 9, 2017. Pegfilgrastim is a long-acting version of the oncology supportive care medication filgrastim (a granulocyte colony-stimulating factor, G-CSF), which stimulates the bone marrow to increase the level of white blood cells (neutrophils) in patients undergoing chemotherapy.

“These findings add to the totality of evidence supporting our proposed biosimilar pegfilgrastim,” according to Sandoz’s global head of development, biopharmaceuticals, Mark Levick, MD, PhD.

Study participants were randomized to receive a single 6-mg subcutaneous injections of biosimilar pegfilgrastim or the reference medication on day 0. After dosing, study participants underwent a 4-week assessment period followed by an 8-week washout period before crossing over to receive the other medication, and were assessed for a further 4 weeks.

The results showed that Sandoz’s 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% CI; 0.97, 1.02) and maximum serum concentration of study medication after administration (90% CI; 1.03, 1.19)_. Secondary endpoints of safety and immunogenicity were also comparable between both groups, the researchers reported.

The FDA rejected Sandoz’s pegfilgrastim biosimilar in July 2016, issuing a complete response letter. Sandoz’s marketing application in Europe for its biosimilar pegfilgrastim is currently being reviewed by the European Medicines Agency for the same indication as the reference biologic.

There are currently no pegfilgrastim biosimilars approved in the United States or European Union, but Sandoz joins developers including Biocon, Cinfa Biotech, USV in developing a prospective product.

Reference

Nakov R, Gattu S, Wang G, Velinova M, Skerjanec A. 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, December 7, 2017. Poster P3-14-10.