Madelaine Feldman, MD: Practical Considerations for Biosimilars

Madelaine Feldman, MD: To get final approval there is phase 3 data at this time, and I think that’s something that should remain at this time. I trust the FDA, and as long as they have that as sort of a mandatory component of the biosimilar approval, I think it should remain. Again, these are autoimmune patients that are taking this, and if you really want prescribers to prescribe biosimilars, you want to do as much as possible to give them confidence that it works in their patients, that there’s not going to be any problems with their patients. And if you take out the phase 3 data, yes, it may save time and it may save money, but if no one is going to prescribe the drug because they have less confidence in it, that point becomes moot. So, the time to get to the approval, once they’re approved, we got that patent thicket. That already is going to set them back, and then they may not ever get on to the formulary. So, you want to do as much as you can to instill confidence in the prescribers out there. And if they think that it hadn’t been tested in that final group of humans, their kinds of patients, they may be less apt to prescribe it.

When we have preferred tiers, as we know, these are all very expensive medications. So, you have to have tried a lower-cost alternative before even getting to a biologic or a biosimilar. Even if biosimilars come in at 30% or 40% off reference prices, which we know probably won’t happen, patients still won’t be able to afford them unless they’re covered by their insurance. And in order to get on to the preferred tier, there are certain requirements that at this point, biosimilars just are not going to be able to make it. They’re new to the market, so they have no market share. Their list price is less, so the [pharmacy benefit managers, PBM] don’t make as much money. Even if they give a 50% discount with a market share of zero, that doesn’t equal a 30% discount on a higher list price with a market share of 50%.

So, I think that’s probably after the patent dance that I’m not going to get into, I think that’s probably going to be the biggest problem. However, if the biosimilar manufacturer does happen to have the market share either in that disease space or in another disease space, it would make it more likely that the biosimilar might be able to get to the market. And I think it’s a shame that safety, efficacy, and lowest list price are not the determining factors for what makes it to the preferred formulary. And if we can make a change with that, then I think the lower cost of biosimilars will actually propel them forward and have a much higher uptake in the United States.

It’s felt that [state-level interchangeability legislation] needs to be passed in order to have biosimilars prescribed and prescriptions filled. Some of the most common criteria for that legislation is that the physician needs to be notified by the pharmacist. How long of a time between the fill of the biosimilar and the notification has been some sticking around the country and various states have different lengths of time, whether it’s 5 days or they actually use the term “within a reasonable amount of time.” The other thing is, how are physicians notified? And I think the electronic interoperability will help not just faxing. That too was a problem with pharmacists. Who’s going to pay for us to do all of this extra work?

And then finally, I think one of the other things is that things are similar in terms of record-keeping. You need to keep a record for several years. And I think we have all but maybe 4 or 5, there’s some sunsetting biosimilar legislation in a few states, but most of the country has passed some type of legislation where the physician, the prescriber gets notified. It’s designated how they get notified, what’s the length of time, and record-keeping.

I probably will sound like a broken record in saying this. I honestly feel that biosimilars will be a great help in reducing the cost of medication because as we continue on, we’re going to have more and more patients taking biosimilars, and more and more biosimilars coming to market. And, if they can’t get on the formulary, no one will be able to take them. So, I think if we can somehow reform that system, the natural flow of biosimilars will occur much more smoothly.

In terms of the future of biosimilars globally, we really think that perhaps there should be some global harmonization to the naming. We didn’t talk about naming in the United States. That seems to have been sort of set by the FDA. But globally, because there are so many varying places with manufacturing and changing of the proprietary names from one country to another, at this time it’s really important that we have some type of standardization in terms of not just the biosimilar but the reference product as well. Then there can be some pharmacovigilance, which some seem to think is overused these days. But I think when we look at the world and some parts of the world may not have the capabilities of pharmacovigilance of others, if we had global harmonization, safety, and the ability to track if there are any adverse events, I think that’s very important.