by Steven Lucio
Senior principal, pharmacy solutions
Ask any pharmacist what pharmaceutical news is top-of-mind right now and they’ll most likely list the end of Humira’s market exclusivity in the top three. Coming late January 2023, the top selling drug in the U.S. (and the world) will have its first biosimilar competitor: Amjevita (adalimumab-atto; Amgen). Then in June, the first interchangeable biosimilar, Cyltezo (adalimumab-adbm; Boehringer Ingelheim), will launch alongside five additional biosimilars for Humira. And there are up to three more in the pipeline pending FDA approval.
While biosimilars have been around for about 10 years with modest uptake, Vizient experts forecast that this new competition for Humira could lead to more expansive adoption of other available biosimilars and begin a dramatic change in the pharmaceutical market.
Following the release of Vizient’s 2022 biosimilars survey, we sat down with Vizient Senior Principal of Pharmacy Solutions Steven Lucio to learn more about what the future of biosimilars holds. Lucio is an expert in biosimilars and has recently been interviewed on the topic by Modern Healthcare, Formulary Watch, Repertoire Magazine, and the Center for Biosimilars.
We’ve talked quite a bit about biosimilars and the Humira patent expiration for a few months now, and we know that at least seven new biosimilars are expected to enter the market next year. So, what’s the dream outcome?
Well, really, it’s that all the products are launched, that they get some measure of uptake, and that the payer community has an approach that treats all of these biosimilars in an equivalent fashion. The payer aspect is key to giving providers more discretion on which agent they choose in order to maximize the clinical and economic benefit to the patient.
Seven competitors for Humira are already approved and more may be on the way. Can the market sustain that many competitors?
We haven’t had this many biosimilar competitors for one product enter the market before, so this is new territory for us. What we have seen in the past with similar situations in the world of generics is that manufacturers typically exit the market when they find they fail to achieve an adequate market share. That said, I wouldn’t expect to see many, if any, drop out until around 2024 or later, because hospital and payer formulary decisions won’t be fully realized until then.
What’s the biggest obstacle facing biosimilar adoption?
Because providers have patients across many payers, much of the adoption process depends on which product the payers will prefer, if any, and what requirements will need to be addressed to manage the patient’s coverage. Payers may choose to stay with the brand originator or only choose one of the biosimilar options. Multiply that across several payers and you have a more complicated ordering process and a higher potential for medication waste because providers would have to manage the inventory of the originator and multiple other related biosimilars.
There’s another element, too, where providers are having to look at how complicated the therapy transition process for a patient will be, and how many prior authorizations they will need to complete to shift a patient from the brand medication to a biosimilar, or from a biosimilar to another biosimilar.
What’s the worst-case scenario if these biosimilars aren’t adopted?
The worst-case scenario is that we launch all these products and they find no uptake. It would be less than desirable if regardless of how much biosimilars are offered for a lower list price to the market, the originator company keeps the market in its entirety or we have excessive fragmentation that affects prior authorizations and complicates transitioning patients between medications.
Our biggest hope is that these biosimilars lead to greater adoption of biosimilars for medications beyond just Humira. If we have limited or no uptake with these biosimilars, it could very possibly curtail any opportunity we have for subsequent biosimilar development following Humira.
What would help with biosimilar adoption?
I think the biggest opportunity that could help with biosimilar adoption really is alignment between payers and providers. It’s hard to navigate the complexity between payer preference and provider need and still provide the best patient care possible.
We often encourage our pharmacy members to talk with their internal managed care colleagues and the team who is negotiating payer agreements to try to encourage equivalent coverage across products.
Ok, so we’re excited, but putting 2023 into context, will the launch of Humira biosimilars be immediately felt?
It’s important to note that this is a big moment, but if we don’t see widespread adoption in 2023 and the savings that follow, we really shouldn’t panic. We need to remember that these biosimilars are coming out in a staggered fashion and payers make their formulary decisions many months in advance. So, with that context, we’re more likely to see the landscape change in 2024, or at the very least, have the financial data necessary to see the financial impact these biosimilars have on the market.
What can biosimilars teach us about the overall experience of medication approvals, competition and pharmaceutical costs?
From the first biosimilar launch seven years ago to now, the process has been a challenge, because biosimilars had to be built from scratch. Prior to 2010, the Food and Drug Administration (FDA) didn’t even have the authority to evaluate these types of products, and prior to 2012, there wasn’t any guidance from the FDA to the industry on how to obtain approval. All of the manufacturers had to learn how to generate the data for biosimilar development, how to engage with the FDA and other regulatory bodies and how to enter this space where competing therapies had not previously existed.
While the challenges between payers and providers have been around since before biosimilars were even a thought, these factors have substantially affected the rate of growth of this new market. Unlike many generics used in the health system, biosimilar value is determined not only by acquisition cost, but reimbursement. Therefore, we must continue the effort to gain the alignment necessary to support this drug category.
Developing and marketing biosimilars is probably the biggest lifelong learning lesson we have in pharmacy, and we should seek to understand these dynamics and learn from this experience. Biosimilars have and will continue to help lower costs for critically important drugs. Also, they represent an opportunity to educate clinicians and the public on how markets work, how medication regulation occurs, how competition is structured, and how the quality of manufacturing can be improved. Biosimilars have had to prove that they’re as safe and reliable as the originator and there’s a lot of insights to be gained from looking at the broader picture.
Recent news featuring Lucio
Interested in learning more about biosimilars? Dive into one of the recent news articles below or read more about Lucio’s work with biosimilars in Vizient’s Breaking it Down: Biologics and Biosimilars with Steven Lucio story.
- Biosimilars to curb drug price hikes next year, report shows, Modern Healthcare
- Humira Biosimilars a Question Mark for Hospitals, Formulary Watch
- New survey from Vizient provides hospital insights in biosimilar adoption, Repertoire Magazine
- Vizient Survey Reveals Provider Motivations for Choosing Biosimilar Over Humira, Center for Biosimilars
About the author
As senior principal, pharmacy solutions, Steven Lucio, PharmD, is responsible for providing education to member organizations and supporting their efforts on various clinical practice topics including improving medication safety, mitigating the impact of drug shortages, benchmarking pharmacy costs for key drug classes, evaluating the expense of high-cost biologics and preparing for the future development of biosimilar medications.
Steven holds a doctorate in pharmacy from Creighton University and a bachelor of science degree in pharmacy from the University of Texas at Austin, and is a board-certified pharmacotherapy specialist. He is lead author of a recently published peer-reviewed article on biosimilars. Steven is an active speaker and panel moderator and has presented his insight on biosimilars more than a dozen times in the past year.