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, pharmacodynamics, and immunogenicity in healthy subjects.
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.
Panelists Call for Consistent Education, Support to Improve Patient Comfort With Biosimilars
May 15th 2024At the Festival of Biologics USA, panelists stressed the need for patient-centered communication and education to boost comfort with biosimilars, emphasizing consistent support from health care providers despite restrictive payer policies.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.