Addressing Hesitance in Biosimilar Adoption

In an interview, Sophia Humphreys, PharmD, discusses how the expansion of biosimilars into new therapeutic areas, such as immunology, endocrinology, and ophthalmology, has led to increased hesitance compared to the quicker adoption seen in cancer treatment. This is due to the maintenance nature of many therapies, making it harder to switch patients to biosimilars.

She emphasizes the need for patient and provider education about the safety, efficacy, and similarity of biosimilars. When addressing adalimumab biosimilars, Humphreys highlights factors such as product formulation preferences, interchangeability regulations, and payer coverage as key drivers in market competition.

This transcript has been edited for clarity.

Transcript

How do new therapeutic classes and indications for biosimilars influence market expansion?

I think this goes beyond just patient education. And, for example, when we started with just the cancer curative and supportive agents, biosimilars, those are quickly adopted, and once we start to move into immunology, endocrinology and ophthalmology, now we started to observe more hesitance.

One reason is because a lot of these are maintenance therapies. So we're not looking at starting a new treatment plan or starting a new cycle treatment with a new biosimilar. We're looking at convincing a patient who has failed several therapies before they reach the [reference] biologics now that could convince them to switch to a biosimilar product. So the first thing is that we really wanted to educate both our patients as well as our providers that these products are highly similar to the reference product.

There's no evidence of diminished efficacy or increased immunogenicity or safety signals so far. For the past 10 years, we have used biosimilar successfully. And also we really wanted to address our health care system leaders that these biosimilar product in the expanded therapeutic classes would really increase access of care—really providing life saving, life altering medications for more patients.

What are the key factors driving competition among adalimumab biosimilars in the market?

Adalimumab, that's everybody's favorite molecule since July of 2023. So, several factors. This is actually quite similar—adalimumab and infliximab. It's almost similar. For autoimmune disease, as we have mentioned, a lot of patients are on maintenance [therapies]. And adalimumab has so many product [options]. And you really want to see if the product can match the existing product that our patient are using as much as possible.

For example, if my patient is using a citrate-free product, you probably don't want to switch them to a product that is not citrate-free, which will cause probably more injection site discomfort. And also, a lot of patients prefer higher concentration vs lower concentration. That's another concern. And interchangeability is another concern.

In a lot of states, we allow pharmacy-level switch, which means when a physician's order is the reference product for adalimumab in the state where they allow pharmacy-level switch, a pharmacist can switch the particular product to a interchangeable biosimilar of the reference adalimumab without a new authorization from the physician who prescribed that originator, because this particular product is interchangeable.

Of course, different states have different regulations, and you also need to make sure that you meet the communication and information sharing requirement of your state, which means the patient needs to know that you're giving them a different product. The physician would need to know when you did the switching and which product was provided to the patient. Of course, most importantly, we need to know if the biosimilar you are switching to is covered by the patient's payers, and if they provide similar or comparable patient support and especially copay assistance.

And when we are working with 340B-eligible sites, you would need to consider the switching effect to your 340B accumulation. So, a lot of factors are brought into this consideration. It's a very comprehensive analysis.