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Pegfilgrastim Biosimilar One Step Closer to FDA Approval

The pharmaceutical company Sandoz recently resubmitted its Biologics License Application to the FDA for a proposed pegfilgrastim biosimilar. Pegfilgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a side effect of chemotherapy that kills 4,000 cancer patients every year in the United States.

A biosimilar is a drug made up of living organisms that is "similar" to another biologic medicine (considered to be the reference product) that is already FDA approved. A biosimilar mirrors the reference product in terms of safety, purity, and potency but may differ in terms of the clinically inactive components it contains. Two biosimilars of another G-CSF, filgrastim, have already been approved by the FDA.

The resubmission includes data from a study that was conducted to compare Sandoz's pegfilgrastim biosimilar with US-sourced reference pegfilgrastim and with EU-sourced reference pegfilgrastim, as well as comparing US- and EU-sourced reference pegfilgrastim.

This phase 1 study, published in Annals of Oncology, revealed that the Sandoz-proposed pegfilgrastim biosimilar and EU-sourced reference biologic have matching pharmacokinetics and pharmacodynamics. Sometimes, with a reference biologic, there is a high intra-and inter-subject variability. However, this study showed in healthy subjects, both the biosimilar and reference drug had the same effect, mechanism, and movement through the body.

"For the tens of thousands of US cancer patients undergoing chemotherapy, treatment options that can be individualized right from the start, such as long- and short-acting filgrastim biosimilars, are key to help manage the risk of serious complications related to infection," commented Mark Levick, MD, PhD, Global Head of Development and Biopharmaceuticals at Sandoz. "The US market is just beginning to benefit from biosimilars, as shown by the success of our filgrastim, the first approved biosimilar in the US. The submission of our pegfilgrastim biosimilar application is another step for us as we continue to lead the way in creating early and expanded patient access to life-changing biologics."

For More Information

Nakov R, Schussler S, Schier-Mumzhiu S, et al (2018). A large multi-center, randomized, double-blind, crossover study in healthy volunteers to compare pharmacokinetics and pharmacodynamics of a proposed biosimilar pegfilgrastim with EU and US reference pegfilgrastim: methodological approach. Ann Oncol, 29(suppl_8). Abstract 1796P. 

Image Courtesy of National Cancer Institute

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