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Ali McBride, PharmD, MS, BCPS: Pharmacists' Concerns About Biosimilar Implementation
Ali McBride, PharmD, MS, BCPS, clinical coordinator of hematology/oncology at the University of Arizona Cancer Center, discusses areas where pharmacists still have questions about biosimilars and their implementation.
Transcript
Other areas which are kind of coming and delving into more discussion in regards to education and other resources is, of course, what will happen for implementation in the near future, and also pharmacovigilance: How are we tracking this? Are we doing a good job of tracking this? Who's running that ship as well?
The last thing, which is still emerging and has not been had guidance yet, is interchangeability.* We're expecting the draft guidance document, which is actually brought back, to be released here shortly, hopefully in May, and that will provide us with more information about how we can actually switch these biosimilars before we can switch these with therapeutic interchange at many hospitals, clinic sites across the board.
But what happens when it goes to a specialty pharmacy outside of your network? Will they be able to switch a pegfilgrastim for self-injection? Will they be able to actually self-inject a short-acting growth factor without contacting the doctor?
We have seen a lot of state laws being passed, and there’s going to be state regulation with state boards of pharmacy, but also the federal law and state law may have to have further discussions as well.
So I think those areas, and hopefully they’re not too much, provide some opportunities for further discussion, and also opportunities for patients who are trying to get these drugs at a lower cost and also improve access as well.
*As of the date of filming. To read about the FDA’s finalized guidance on interchangeability, click here.
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.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
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.
Breaking Barriers in Osteoporosis Care: New Denosumab Biosimilars Wyost, Jubbonti Approved
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