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Gary Lyman, MD, MPH: Biosimilar Epoetin Alfa in Cancer Care
Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses the role of the first FDA-approved biosimilar epoetin alfa in cancer care.
Transcript
So the first biosimilar, in fact the only biosimilar in the United States, was approved nearly 2 years ago* and it was based, as I indicated, largely on the preclinical work and pharmacokinetic, pharmacodynamic data and healthy volunteers.
They did run 2 large phase 3 trials, but in patients with chronic kidney disease, not in cancer patients. So in actual fact, the only data on cancer patients with the epoetin alfa biosimilar is observational, not randomized controlled trial data.
Now, it turns out that there is this drug is also available in Europe, known as epoetin zeta. It's essentially the same molecule that’s been approved in Europe. There, they have done large phase 3 trials in patients with cancer showing noninferiority to the originator epoetin alfa. No safety concerns, no immunogenicity concerns.
So the FDA was willing to accept the data from the same drug in Europe plus demonstration of safety and efficacy in advanced kidney failure patients in the United States and say “this should work the same for supporting patients with chemotherapy-induced anemia.”
That indication is not nearly as frequent as it used to be. A lot of concern was raised a few years ago, so the use of these agents as opposed to transfusions has fallen off in the United States, but nonetheless, to have competitive biosimilar versions to lower the prices of these drugs hopefully will work to the advantage of of patients in the overall healthcare system.
*Retacrit was approved by the FDA in May 2018.
Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
IGBA 2023: Dr Monique Mansoura Highlights the Intersection of Geopolitical Issues, Biopharma
February 19th 2023COVID-19 allowed governments to critically examine the biopharma space to increase access to vaccines, but there's still a way to go, according to Monique Mansoura, PhD, MBA, executive director of global health security and biotechnology at the MITRE Corporation, at the International Generic and Biosimilar Medicines Association’s annual meeting.
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.
