Limiting Quantity of Available Biosimilars


A discussion on limiting the number of biosimilars available for the same product at an institution regarding inventory, fridge space, and safety.

Anthony Mato, MD, MSCE: Does anyone know if the FDA provides guidance on the process of consent when switching from an agent, from a biologic to a biosimilar? Is there any guidance that we have about that process?

Bhavesh Shah, RPh, BCOP: They do not have any guidance. Actually, in the LISTSERVs, we’ve seen a lot of comments from institutions that have changed their consent to just bevacizumab products, for example, or Rituxan, rituximab products, so patients don’t have to reconsent it if they’re switching from a reference to a biosimilar.

Anthony Mato, MD, MSCE: Got it. Do you think there’s room on formularies for more than 1 biosimilar of the same product? If you talk about 5 of 1 agent, is there a limit, in terms of your own institution, on what number of biosimilars you think should be available? I’m sure that takes up shelf space in the pharmacy at a minimum. What are your thoughts about that?

Tim Peterson, PharmD, BCOP: I think that’s going to be 1 of the biggest difficulties from a pharmacy standpoint with these. For example, for the 5 trastuzumab biosimilars we have, I’m not certain if all of them have all the indications or some of them have some of the skinny-label indications. But that may drive which agency you choose versus just seeing commercial payers, which ones they’re giving preference to. You may be able to elucidate which would be more appropriate just based on the number of patients who are likely going to require that.

An interesting thing, which Marc touched on: some of the operational signs of having multiple agents. But it’d be interesting to hear about the administrative burden if you were to have 5 different biosimilars for trastuzumab, even the originator Herceptin, and then you have Herceptin Hylecta [trastuzumab and hyaluronidase-oysk]. What type of additional burden does that give you from an operational standpoint? Do you need additional staffing to take care of these inventory things? I think that would be an interesting question too.

Marc Earl, PharmD, BCOP: I think about it from an inventory standpoint. No. 1, I agree. I don’t have room to handle that many products. But safety is big in oncology as well. When we have multiple different products with different names that can be interchanged, you set yourself up for error and risk. For us, I would love to have 1 preferred biosimilar. You may have a secondary preferred product for some payer mandates, but that would be a way to try to reduce the inventory, increase safety, and free up a little bit of fridge space as well.

Bhavesh Shah, RPh, BCOP: Obviously it’s a significant operational nightmare to have more than 1 biosimilar because of all the coding and billing that you have to keep up with—not just the inventory but all the prior authorizations. A lot of administrative things go into having multiple formulations.

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