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The first biosimilar to Humira is here. Now what?

Robust pipeline is expected to bring significant savings in the autoimmune category


Joshua Fredell, PharmD, Vice President and Head of PBM & Specialty Product Innovation


The launch of Amgen’s Amjevita — the first of many Humira biosimilars expected to launch in 2023 and 2024 — presents an opportunity to meaningfully reduce drug costs. Over the next two years, we expect plan sponsors to benefit from significant savings in the autoimmune categories where biosimilar competition exists.


Biosimilars in the Autoimmune Category – Opportunities and Considerations

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What payors need to know

We’ve seen that these products can create competition that drives significant savings. Our primer, Biosimilars in the Autoimmune Category – Opportunities and Considerations, highlights the complex factors that affect formulary decisions around biosimilars.

It explores upcoming entrants in the autoimmune category and how our approach is aligned to our lowest net cost strategy, providing our clients with maximum savings, while providing members coverage of clinically safe, effective medications and ensuring continuity of care.


Reviewing new-to-market biosimilars

A thoughtful approach to assessing new products is key to informing our lowest net cost strategy. New biosimilars undergo our proven new-to-market evaluation. With each entrant, we review cost and clinical considerations, including formulation, delivery mechanism, sufficient supply, and member experience.

We'll continue to use this framework to evaluate additional products as they come to market. Our strategy will evolve with the expected launch of up to 10 Humira biosimilars in 2023 followed by anticipated biosimilars for Stelara in 2024.


Josh Fredell explains our new-to-market evaluation


New to market evaluation is a process we take on newly launched drugs.

This could be a new biosimilar, or a new drug in general.

We simply pause.

We allow internal and external clinical experts to take a look at this product.

Is it gonna deliver benefits in terms of its clinical effectiveness, in its safety? Will it provide advantages and benefits in terms of cost?

If not, we may not add it to our formulary immediately.

This allows time to continue to evaluate that product while allowing existing utilizers on the existing medication that's available to stay on that medication without any change.

But if a product, of course, through that new to market evaluation, provides true advantages and benefits, we'll typically add it to our formulary, providing new options, new access, and new competition in that category.

When we evaluate any medication for our formulary, whether it's a new drug or a biosimilar, a competitor to an existing product, we evaluate several things to make sure we make the very best decision in terms of adding that product to the formulary.

First, we're gonna look at the clinical effectiveness and safety.

Does this product bring advantages in any of those spaces?

We're certainly gonna look at cost, not only the actual cost of this new drug, but does it help lower the overall cost of care in that given category?

And then finally, we're gonna look at several product attributes. So, looking at this new drug, does it have the right formulation?

So, is it the similar or the same concentration as the existing drug?

We're gonna look at the delivery mechanism.

For many biologic specialty drugs, they have to be injected.

So is the device, the process of administering the drug the same or better than what we have in existing products?

That's very important for patient care.

We're gonna look at supply.

Can the manufacturer make enough to supply the market

if a formulary change is to be made?

And then also we're gonna look at the member experience.

Does the manufacturer and other things surrounding the drug that support patient adherence and access to care, are they present on this new drug?

And if not, all of these things need to be evaluated to make sure we make
the very best decision when determining bringing a product in to our formulary.

With each biosimilar launch, we’re focused on making the best decision – one that maximizes savings for payors and minimizes disruption for members.

This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.

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