Biosimilars boom: The next era of adoption

The evolution of the biosimilar market

For sponsors of the pharmacy benefit, the arrival of biosimilar alternatives to expensive specialty medications such as Humira® (adalimumab) is one of the most fiscally relevant events in recent years.

To learn how the biosimilar market has evolved since the introduction of Humira biosimilars in 2023, Optum Rx Senior Vice President of Clinical Consulting, Scott Draeger, welcomed back Optum Rx senior vice president of industry relations, Jamey Millar, and Optum Rx senior vice president of formulary management, Savitha Vivian, for a new discussion on the Pharmacy Insights Podcast.

Read on for excerpts of their conversation, and listen to the “Biosimilar Boom: The Next Era of Adoption” episode.

Scott Draeger: Savitha, by now there is a growing familiarity with biosimilars as a concept. But can you give us a quick recap of why they're important?

Savitha Vivian: Biologic drugs are a primary driver of pharmacy spending. They are made of complex molecules and are often used for rare, complex diseases. They are considered to be specialty drugs and we know that while specialty drugs only make up 2% of all prescriptions that are filled, they account for 50% of drug spend. So, they make a huge impact on plan sponsors and members in terms of drug cost.

Biosimilars are intended to encourage competition for expensive biologic drugs. Having more products on the market drives that competition, leading to lower prices. So, biosimilars help maintain choice for providers and members by providing the same quality of care at a lower price.

In the last two years we’ve seen the introduction of biosimilars for Humira, which is the top-selling drug of all time. This provided an opening to drive meaningful savings in a high-cost specialty drug category. The presence of multiple biosimilar competitors allowed us to leverage our negotiating ability not only for better prices for the biosimilars, but also to achieve better value on the brand Humira. So, we leveraged the fact that there were almost a dozen biosimilars available, coupled with our formulary strategy and added up to three of the biosimilars on our formularies. This drove down costs and provided savings for our plan sponsors and members.

Scott: Jamey, it’s the Fall of 2024. Two questions. First, how would you describe the Humira biosimilar market as it sits today? Second, can you give us a sense of how you assess the merits of new biosimilars and the criteria that you use to help determine formulary selection?

Jamey Millar: Thanks, Scott. Relative to your first question, I think the market for adalimumab biosimilars is still evolving. The first couple of years were transitional and that was a function of the timing and sequence of the launches. If you think back to 2023 and the beginning of the plan year, we did see the first biosimilar, Amjevita from Amgen, launch at the end of January, early February. So, it wasn’t in sync with the beginning of your typical plan design. Then you saw a number of biosimilars launch in a staggered fashion throughout the rest of the year.

The other component was the development programs of these biosimilar manufacturers continued to mature. Some of the non-clinical product features and attributes are continuing to develop over time. For example, not all of the adalimumab biosimilars were citrate free or high concentration formulations. Some had an interchangeability designation, some didn’t.

Some manufacturers didn't have all the doses. So, the manufacturers have continued to invest in developing out the product features and characteristics.

And now as we head toward the end of 2024, I think we've got a very mature product marketplace in terms of a settling out of pricing based on leveraged competition as well as maturity of these product features. That’s why I think we're primed for a fairly significant shift as we start 2025, and our 2025 formulary strategy reflects that attitude.

Scott: The Humira biosimilars really gave us the first biosimilars of consequence within the pharmacy benefit. Savitha, considering what Jamey just said, can you expand on what lessons have we learned and how will this impact the way that Optum Rx formularies will treat Humira and its biosimilars in 2025?

Savitha: As Jamey noted, there are a variety of biosimilars available and we initially added three at parity with Humira on our formularies. What we learned was that members and providers didn't really want to switch off of Humira to biosimilars at that parity position. If given a choice to stay on Humira or move to a biosimilar we didn't see a lot of members opting to switch, which I don't think was surprising. So, I think one thing we learned is that interchangeability, where the pharmacies can actually substitute the biosimilar for the innovator brand, is important so that those switches can happen at the pharmacy without the involvement of providers and members – especially when we're looking at a parity position.

Our clients have also informed us that simplicity is something that's to be desired.

So with three biosimilars on the formulary, the message kind of gets confusing on what's preferred and what's not preferred. So for 2025, we're going from three preferred biosimilars down to one preferred biosimilar, which is both a high list price and a low list price version of Amjevita.

And we feel like our choice of Amjevita aligns with our guiding principles. We have continued quality care for patients by choosing an FDA-approved interchangeable biosimilar. Amjevita will be interchangeable, pharmacies can assist in seamlessly moving patients off of innovator brand to biosimilars. We have stable supply in the Amjevita product, which also adds to continuity of care. Also, the Amjevita product provides all the formulations and strengths that Humira comes in, so there isn't anything lacking for a specific population so that they can't switch off of Humira and onto the biosimilar.

Lastly, this selection continues to provide affordability not only to our plan sponsors, but also to our members through zero-dollar copay assistance programs.

Scott: These seem like significant changes. Savitha, you mentioned the initial lack of movement of members off of branded Humira. How does the organization plan to bring providers and patients along to embrace the use of biosimilars?

Savitha: We know that interchangeability was an important guiding principle in formulary selection and we are preferring a product that has interchangeable designation. But we are finding that there is an exclusivity period that exists for other therapies that already have this designation. This may not allow the pharmacies to interchange automatically on January 1st when we put our new biosimilar strategy into place.

So, to ensure continuity of care, we're allowing existing branded Humira patients to be able to continue on therapy without switching until those preferred biosimilars are interchangeable without a new prescription. When that exclusivity period ends, we will ensure that biosimilar uptake is increased.

Another way to increase biosimilar uptake is to ensure that patients are provided with affordable alternatives. We chose a biosimilar that has a zero-dollar copay assistance program. We're also working with our plan sponsors to help them make the best decisions for their members. In addition to that, we'll also be reaching out to pharmacies to help them prepare for the change by providing them the resources to facilitate the switch. We are also letting them know what the formulary alternatives are ahead of time, helping them with things such as the prior authorization (PA) process and making that as seamless as possible for them.

And then lastly, we are following all of this up with provider education. We are notifying providers of when the changes are going into place, letting them know what the preferred alternatives are, and also helping them through the PA process by ensuring PA approvals are already available for the biosimilar.

Scott: Jamey, you and I've been in the industry a long time. I think the hope of biosimilars has always been focused on their anticipated ability to help mitigate specialty drug spend. What type of financial impact can plan sponsors expect through the adoption of Humira biosimilars?

Jamey: Yeah, great question. I would say that even in the last two years with the biosimilars at a parity formulary position we've already delivered significant net cost savings for our clients. As has been the case with other biosimilar introductions, the value that's extracted through competition comes not only from the biosimilar pricing but also from the price concessions that makers of the innovator product are required to make in order to maintain a competitive market position.

Even with biosimilars in the parity formulary position, utilization of adalimumab in 2023 and 2024 occurred at a much lower net cost for clients than in previous years when Humira had exclusivity in the marketplace. So, as we look forward to 2025, the additional levers in terms of formulary actions as well as pharmacist ease of conversion through interchangeability designations will be able to obtain even greater net savings for clients.

Just to give you an example, the low wholesale acquisition cost (WAC) Amjevita product comes at an 83% discount to the list price of branded Humira. This option continues in 2025, allowing clients to choose a high WAC Amjevita with rebates or low WAC Amjevita at a low list price. So, the opportunity is there for clients to achieve further net cost savings.

Scott: Savitha, we’ve focused our discussion on Humira but we know that there are many other expensive biological medications. Where is the biosimilar market going and what other drug categories can we expect to see approaches similar to what we are seeing with Humira biosimilars?

Savitha: Before I get to where the market is going, it might be beneficial just to reflect on where we've been and where we're at. The first biosimilar was approved by the FDA eight years ago. In 2024, we now have 46 biosimilars available for 11 different biologic brands. And in that time frame, we're finding that biosimilars now are on average 50% lower than the brand biologic products. As Jamey noted, in the in the case of the Amjevita choice that we've made, it comes at 83% off of the Humira list price. So, we ‘ve made significant advances in the number of biosimilars and the cost of benefits that they afford.

Looking forward, we just went through Humira, which was one of the biggest biosimilar launches. What's next is more drugs in the immunomodulator space for conditions like psoriasis, psoriatic arthritis and rheumatoid arthritis. So, we're expecting the next big biosimilar launch to be the biosimilar for Stelara® in 2025. In fact, we anticipate the first one to launch in January, followed by two others in February.

Some other high-cost specialty drugs with biosimilars we are expecting include Prolia® and which is for osteoporosis, Cimzia® for Crohn's disease and Trulicity®, which is for diabetes.

So many more biosimilars are still on the horizon. With any upcoming biosimilar launch, I think we have already developed a really stable and sound set of guiding principles to that will help direct our choice in which products to choose.