The Armamentarium of Biosimilars Becomes More Robust

Published: Wednesday, Nov 13, 2019
Hope Rugo, MD

Hope Rugo, MD

The slate of biosimilars for cancer is growing, and with this expansion the potential for price competition has improved. In November 2019, LA-EP2006 (pegfilgrastim-bmez; Ziextenzo) became the sixth biosimilar for cancer to get FDA clearance so far this year and the 15th biosimilar indicated for cancer on the US market (Figure).1 Unlike generic drugs, biosimilars slightly differ from their reference or originator drugs and therefore undergo a separate FDA review process. In US oncology, the use of biosimilars dates to 2015, when the FDA accepted filgrastim-sndz (Zarxio).

Figure. FDA-Approved Biosimilars for Patients with Cancer

Figure. FDA-Approved Biosimilars for Patients with Cancer

References

  1. Biosimilar product information. FDA website. www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed July 2, 2019.
  2. Davio K. FDA finalizes guidance on interchangeable biosimilars. The Center for Biosimilars® website. centerforbiosimilars.com/news/fda-finalizes-guidance-on-interchangeable-biosimilars. Published May 10, 2019. Accessed July 8, 2019.
  3. Brennan Z. Updated: interchangeable biosimilars: FDA finalizes guidance. Regulatory Affairs Professionals Society. Published May 2019. https://www.raps.org/news-and-articles/news-articles/2019/5/interchangeable-biosimilars-fda-finalizes-guidance. Accessed July 8, 2019.
  4. Christl L. FDA’s overview of the regulatory guidance for the development and approval of biosimilar products in the US. FDA website. www.fda.gov/drugs/published/FDA%E2%80%99s-Overview-of-the-Regulatory-Guidance-for-the-Development-and-Approval-of-Biosimilar-Products-in-the-US.pdf. Updated January 2, 2015. Accessed July 8, 2019.
  5. Rugo HS. Dr. Rugo discusses regulatory process behind biosimilars. OncLive® website. onclive.com/onclive-tv/dr-rugo-discusses-regulatory-process-behind-biosimilars. Published April 3, 2019. Accessed July 2, 2019.
  6. Fanjiang G. Biosimilars in cancer care: potentially improving patient access to essential therapies. OncLive® website. onclive.com/sponsored/biosimilars-in-cancer-care-potentially-improving-patient-access-to-essential-therapies/?p=1. Published June 17, 2019. Accessed July 2, 2019.
  7. Davio K. Pfizer confirms that it has terminated 5 preclinical biosimilar programs. The Center for Biosimilars® website. centerforbiosimilars.com/news/pfizer-confirms-that-it-has-terminated-5-preclinical-biosimilar-programs. Published January 15, 2019. Accessed July 8, 2019.
  8. Aitken M, Kleinrock M, Simorellis A, et al; IQVIA Institute for Human Data Science. The global use of medicine in 2019 and outlook to 2023. IQVIA website. iqvia.com/institute/reports/the-global-use-of-medicine-in-2019-and-outlook-to-2023. Published January 29, 2019. Accessed July 8, 2019.

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