Tyler Sandahl, PharmD, is a clinical pharmacist at Mayo Clinic.

Tyler Sandahl, PharmD

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic.

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, welcomes the advent of biosimilars in multiple myeloma treatment, particularly a potential biosimilar for daratumumab, as a means to reduce costs and increase market competition. However, she foresees significant challenges, especially if an intravenous (IV) biosimilar becomes available before a subcutaneous version.

The FDA approved Celltrion's investigational new drug application for CT-P44, a daratumumab biosimilar, enabling a global phase 3 trial.

 Researchers will evaluate CT-P44's pharmacokinetics, efficacy, and safety against daratumumab in 486 patients with refractory or relapsed multiple myeloma.


Sandahl notes that the original IV daratumumab infusions can take 8 to 10 hours, creating considerable scheduling difficulties. She explains that even with current patient volumes and nursing shortages, switching just a few patients from subcutaneous back to IV has proven challenging for infusion centers.


While acknowledging the clear cost containment benefits of biosimilars, she emphasizes that the cost difference would need to be substantial to justify moving patients from the more convenient and less chair-time-intensive subcutaneous formulation back to an IV one. She questions how centers managed this logistical burden universally before the subcutaneous option became available, highlighting a potential conflict between cost savings and current clinical practice efficiency.

This transcript was lightly edited for clarity.

: Please discuss the potential impact of biosimilars on the treatment paradigm of multiple myeloma. How might the growing availability of biosimilars influence prescribing patterns, cost management, and the role pharmacists play in integrating them into practice?

As a pharmacist, I welcome biosimilars and generic medications, anything we can do to reduce costs and increase competition. I think one thing that I've thought about is a biosimilar for daratumumab because that's probably the first one we would see, based on when things were approved. I'm curious what the adoption of that would look like because you'd see a biosimilar most likely for the IV formulation sooner than you would with the subcutaneous, and that's a huge difference in chair time. The cost difference would have to be pretty substantial for people to say, "Hey, we're putting everyone on the daratumumab biosimilar and abandoning the subcutaneous Darzalex."

I think it'd be an interesting change in practice because the way our things stood, the first infusion for IV daratumumab can take 8 to 10 hours, and scheduling that can be really challenging. We've had a few patients in the last couple of months who have needed to be switched from subcutaneous to IV for some reason or another, and even just finding them a space in the infusion center to get those first couple infusions has been a huge challenge. Where I've gone back, I'm like, "Gosh, how did we do this for everyone before we had subcutaneous? How did we make this work before because now we can't seem to?"

Some of that is an increase in patient volumes and differences in nursing shortages that maybe we didn't have 5 to 6 years ago. I think from a cost containment standpoint, biosimilars would be great but then when we look at like clinical practice and how that fits with current practice, going from subcutaneous back to IV would be a challenge.

FDA approves global phase 3 trial for Celltrion’s daratumumab biosimilar. Pearce IP. December 27, 2024. Accessed July 14, 2025. 

https://www.pearceip.law/2024/12/27/fda-approves-global-phase-3-trial-for-celltrions-daratumumab-biosimilar/

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Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.

Tyler Sandahl, PharmD

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