Dr Alan Carter on Biosimilars in the Insulin Market

Alan Carter, PharmD, principal investigator and senior advisor at MRIGlobal, and adjunct faculty at University of Missouri­—Kansas City School of Pharmacy discusses the influence of biosimilars and follow-ons in the insulin market and their reliability should be validated.

Transcript (slightly modified)

Will we see “biosimilar” or follow-on insulins impact the insulin market?

I think they will and I think they will have a relatively positive impact on price, but again, because the pharmacy benefit managers will be involved in negotiations and since they are follow-ons, they are not technically a generic. There is not an automatic substitution rule, but that could vary between state to state, since some states will allow substitution, if its interchangeable without notifying a physician or practitioner that wrote the prescription, by the pharmacy. That creates a mail-order issue, where it could show up on a patient’s door step with a letter inside it saying “your product has been substituted for this product, your physician has been notified. If you have any questions, call this number.” That’s all they are required to do.

But with a diabetes patient, and now that we have multiple branches of unit strengths, such as Toujeo 100 units versus 200 units, it’s much cheaper to use a 200 unit per 100 unit dose if they substitute that and the patient doesn’t understand that they have to give half their dose—there’re going to be dosing errors. We standardized 100 units per milliliter a long time ago because there were dosing errors based on 30, 50, 100 unit dose vials, and we had syringes specifically made for each strength. We had a lot of patients end up overdosing on insulin by getting the 100 units instead and that can very easily happen in this scenario.

You have to worry about the biosimilars and follow-ons too because we’ve seen in generic products that are made in other countries, the quality is sometimes excellent but the quality is sometimes not and the FDA never does an inspection on the quality directly of the drug itself. They don’t pull a sample from the pipeline and do analytical work on it ever after it is approved. The only reason they look into it is if a certain number of people die or get sick in a very short period of time, then they start digging into why.

I believe we should have an ongoing prospective review of drugs where we pull some out of the pharmaceutical supply line, either from the pharmacy directly or from the wholesaler, at random fashion and run an analytical review of that through a qualified laboratory and compare that to what is expected to be found. If it does not match we can go the manufacturer and say “what’s up with this? Is this lot potentially bad?” If they know you’re looking at them, they’ll be a little more careful, but since no one is looking, there is no reason to be careful. Ethical companies will be, but those that are not so much, will not be because they have to keep their doors open at the low price they are forced to sell it at. We’ve seen that happen in oversee manufacturers, where the price is too low and even at their lower labor rates they can’t keep it open, so they cheat. Eventually when you cheat, someone gets hurt and I don’t want my patients or myself to get hurt.