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.
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The last thing, which is still emerging and has not been had guidance yet, is interchangeability.* We're expecting the draft guidance document, which is actually brought back, to be released here shortly, hopefully in May, and that will provide us with more information about how we can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.