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Regulatory Decisions, New Data Propel Progress With Biosimilars in Oncology

Gina Columbus
Published: Friday, Sep 20, 2019

The uptick of biosimilars has led to a surge of new data and regulatory decisions in recent years, with a focus on similarity between biosimilars and their reference products while reducing healthcare costs. This week, data on subcutaneous formulations of one biosimilar and long-term experience with another were provided, as well as an authorization of a trastuzumab (Herceptin) biosimilar in Canada.

Overall, the data supported the totality of evidence and can reassure healthcare professionals with the efficacy and safety of the filgrastim biosimilar. Moreover, the extrapolation of data, and specifically acceptance of this biosimilar for widespread use, also has led to a paved path for others to recognize new biosimilars.


  1. Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-overexpressing breast cancer for certain indications [news release]. Incheon, South Korea, and Jerusalem, Israel: Celltrion. Published December 14, 2018." . Accessed December 17, 2018.
  2. Esteva FJ, Baranau YV, Baryash V, et al. Efficacy and safety of CT-P6 versus reference trastuzumab in HER2-positive early breast cancer: updated results of a randomised phase 3 trial [published online August 19, 2019]. Cancer Chemother Pharmacol. doi: 10.1007/s00280-019-03920-4.
  3. Fishbane S, Spinowitz BS, Wisemandle WA, Martin NE. Randomized controlled trial of subcutaneous epoetin alfa-epbx versus epoetin alfa in end-stage kidney disease. Kidney Int Rep. 2019;4(9):1235-1247. doi: 10.1016/j.ekir.2019.05.010.
  4. Gascon P, Krendyukov A, Mathieson N, Mathieson N, Natek M, Aapro M. Extrapolation in practice: lessons from 10 years with biosimilar filgrastim [published online August 22, 2019]. BioDrugs. doi: 10.1007/s40259-019-00373-2.

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