Bioequivalence Studies: Doxil vs. Sun Pharma and Abraxane vs. Genexol-PM

The NCL recently completed a 2.5 year interagency collaboration with the US Food and Drug Administration (FDA) to evaluate the bioequivalence of marketed nanomedicines. The complexity of nanomedicine drug formulations poses unique scientific challenges. And, with the influx of generic versions of several nanomedicines now nearing clinical evaluation, these formulations pose unique regulatory hurdles as well. To help address these challenges, the NCL conducted in vitro and in vivo head-to-head comparisons of innovator and approved generic nanomedicines, using the stable isotope ultrafiltration assay (SITUA) developed at the NCL. These studies were then used to assess the potential of this bioanalytical assay as a new tool to determine the bioequivalence of nanomedicines.

Two controlled release nanomedicine products, Janssen’s Doxil® and Sun Pharma’s doxorubicin HCl liposome formulations, and two fast-releasing nanomedicine products, Celgene’s Abraxane® and Samyang’s Genexol-PM (approved in South Korea) were studied. The results of these studies have just been published on the FDA’s website: https://www.fda.gov/drugs/generic-drugs/generic-drugs-guidances-reports.

These in vitro and in vivo assays are available to interested investigators, as Technical Services NCL-01 and NCL-02, respectively. Details on the technical services can be found here, https://ncl.cancer.gov/working-ncl/technical-services. Please feel free to contact us (ncl@mail.nih.gov) for questions or to discuss the specifics of your nanomedicine formulations.

References:

  1. Skoczen, S., S.E. McNeil, and S.T. Stern, Stable isotope method to measure drug release from nanomedicines. J Control Release, 2015, 220(Pt A), 169-174.  PMID: 26596375
  2. Skoczen SL, Stern ST. Improved Ultrafiltration Method to Measure Drug Release from Nanomedicines Utilizing a Stable Isotope Tracer, in Characterization of nanoparticles intended for drug delivery, S. McNeil, Editor. Methods in Molecular Biology. Vol. 1628, 2018, Humana Press, New York, NY. p. 223-239.  PMID: 29039106