Maximizing Impact During the “Golden Decade” of Biosimilars
Patent expirations create potential for savings, but perception and system complexity challenge biosimilar adoption.
Biologics are complex, high-value drugs used in autoimmunity and oncology for their precision in targeting specific immune pathways.
Unlike traditional chemically synthesized drugs, biologics are derived from living organisms—plants, microorganisms, and animal cells. This enables them to mimic naturally occurring proteins and “lock on” to targets while generally leaving the rest of the body largely untouched. This is dissimilar to alternative immunomodulators, such as steroids, which can cause an array of systemic side effects in their efforts to dampen disease pathways.
Patients who commence biologic treatment often report significant symptom relief, though optimal uptake is limited by several barriers. Costs are high due to manufacturing complexities, logistical challenges can render clinic administration unfeasible, and clinicians report prescribing hesitancy for several reasons, including safety risks.
Enter biosimilars—an opportunity to increase access to life-changing immunomodulation therapies through reducing costs without impacting efficacy. As the name would suggest, biosimilars are highly similar versions of approved biologics that can enter the market once the original biologic loses exclusivity. While biosimilars cannot be exact structural matches, they undergo rigorous testing and evidentiary scrutiny to ensure clinical equivalence is met. However, logistical challenges remain, and prescribing hesitancy is only compounded as new and “unknown” biosimilars enter the market.
As we enter the “golden decade” of patent expirations, Technology Networks spoke with Dracey Poore, director of biosimilars at Cardinal Health, to understand how this period can be leveraged to benefit patients, providers, and payers alike. Poore explored how clinical perception has evolved in recent years, but explained that barriers to adoption persist, as highlighted in Cardinal Health’s recent biosimilars report. Having monitored biosimilars prior to their US market entry, Poore is enthusiastic about how increased uptake could not only improve outcomes for individual patients but also for entire healthcare systems.
What originally drew you to working in biosimilars, and how has your work evolved since entering the field?
Dracey Poore, MSc (DP):
I've been in healthcare my entire career. I worked at a home health organization and then in a hospice, where I provided nursing care and bereavement support. So, I've always worked in healthcare and with patients, until I made the move over to the pharmaceutical industry later in my career.
I was aware of biosimilars quite a while before they came to the United States, and I had been waiting for cost-effective alternatives for patients on biologic treatments. Biosimilars have been in Europe for 20 years; in fact, they just celebrated the 20th anniversary of biosimilars. So, I was excited when I heard about the 351(k) pathway in the United States and that we would start bringing biosimilars to market.
351k pathway
The 351k pathway is a regulatory process that allows biopharmaceutical companies to bring biosimilars to market in the United States without conducting full-scale clinical efficacy trials. The US Food and Drug Administration (FDA) evaluates whether a biosimilar is sufficiently similar to its reference biological based on the totality of evidence available, including animal studies, human pharmacokinetic data, and analytical studies.
I've always found that no matter where I've worked, whether it was a hospital system, a pharmaceutical company, or at Cardinal Health, I have been in organizations that always prioritize patients. That has been consistent throughout my entire career, and that is very important to me.
IH:
With a wave of biologics approaching loss of exclusivity, what does this moment represent for the biosimilars market?
DP:
It’s a great opportunity to bring more savings into the system. But we are hitting a pivotal time point, as we're also experiencing the biosimilar void. We have 118 biologics losing patent exclusivity in the next decade, although only 10% have biosimilars in the pipeline. We need more manufacturers to invest in biosimilars and strengthen the pipeline's robustness. Otherwise, we're looking at a potential loss of over $230 billion in missed savings.
This is an exciting time, and people have just started labeling it the “golden decade” of patent losses.
Positively, the FDA is now moving toward regulatory harmonization and streamlining development to reduce the cost and time required to bring biosimilars to market. We hope this will encourage more investment, as we have some great manufacturers committed to the biosimilar space, and we are all aligned on making the most of this golden decade. In particular, I would like to see products enter the market for biologics that currently have nothing in the pipeline.
IH:
What factors determine whether a biosimilar launch succeeds or struggles as more competitors enter the same therapeutic categories?
DP:
There are several factors that matter. I have been part of three biosimilar launches, and there are a lot of moving parts. Firstly, operational support is imperative. We know that, for providers, the administrative complexities of using a biosimilar can be quite a barrier to adoption. To ensure a successful launch, the manufacturer needs support in setting up operational practices. Reliable supply is equally important. Our latest report showed that practices are looking for a long-term partner; they need to be able to count on you to have a supply month over month for their patients.
Reimbursement predictability is also key. Our research showed that 94% of practices felt stable reimbursement was either somewhat or very important—they're looking for predictability and stability.
Additionally, payer alignment and formulary positioning came up as really important for a successful launch. We found that 50% of respondents felt that payer mandates influenced adoption, and 61% said payers could incentivize their practice to switch from one biosimilar to another.
Lastly, clinical confidence and education are imperative. Our research showed growth in physician confidence, with 99% of the practices either confident or somewhat confident with using biosimilars. However, it is important to remember that as biosimilars launch into new therapeutic areas, we will need to start over with building clinical confidence.
Regarding education, there are some specific areas we still need to work on. One of those is interchangeability. There's still confusion around this, which is part of the reason we maintain our interchangeability map on our website. It's a resource for people to go to; they can click on their state, and their guidelines will come up.
When considering launch strategies, all these things matter.
IH:
What do you see as the largest remaining barriers to biosimilar adoption—clinical perception, policy, or system complexity?
DP:
There are still a few barriers. As we enter new therapeutic areas, we have to go back to that clinical perception. We now understand that pharmacists are critical in biosimilar adoption. 10 years ago, we were focused on education for providers, doctors, and nurses. But we have found pharmacists often carry the onus of having the conversation with the patient. Pharmacists are also often managing the net revenue institutions—they need to understand price, discounts, and reimbursement—so their role as a stakeholder in biosimilar adoption is critical.
Within the overall market, the biggest challenge is lifecycle management, which affects the long-term stability of reimbursement. This needs to align with the average sales price (ASP) of a biosimilar quarter over quarter. For example, if a clinic is using a product and they are reimbursed enough to cover their expenses for one quarter, but then not for the next, this can stir up some real operational complexities. They might even need to switch patients. We receive feedback on the impact of this from both the buying and selling sides. It is important that reimbursement remains stable, and that can only happen if the manufacturer has a strong lifecycle management process. We are currently investigating options to make some alterations to ASP reimbursement, which could incentivize further biosimilar adoption. I also think AI could have a role here, in helping the practices navigate the complexities of reimbursement.
Administrative complexities are the other biggest challenge, and that has remained since the very beginning. I've interviewed many administrators over the years, and while it has gotten better, it is still a barrier. It's been 10 years and there are some new challenges, and some existing challenges. I'd love to answer that question again in another 10 years and see where we are.
IH:
What are the benefits of achieving broader biosimilar adoption for patients, providers, and payers?
DP:
Biosimilars bring savings, and that's a systemic benefit. But there are niche benefits to different stakeholders. From a patient perspective, there are increased treatment options, and they are potentially less out of pocket—not guaranteed, but it's possible because of reduced drug cost. You still have safety and efficacy, but at a more cost-effective rate.
Providers also benefit from greater flexibility in treatment options, as well as improved supply chain. For example, a decade ago, a physician had one infliximab product they could use for rheumatoid arthritis. What if that one drug was low on supply? Now, there are five. So, we have a more robust supply chain because we have more options in the market. That is beneficial for providers when they're prescribing drugs for patients. They also observe improved financial stability, as biosimilars are effective tools for mitigating rising costs.
For payers, the reduced drug spend is most significant. Ultimately, one of the biggest benefits is that the savings can fund future innovation.
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