This article was originally published in Drug Channels.
While the U.S. has been frustratingly slow to embrace biosimilars, the next few years are poised to see a veritable boom in new market entrants. Only six biosimilars were available at the end of 2018. There are now around 40 biosimilars approved in the U.S. across multiple indications. Plus, enrollment in the FDA’s Biosimilar Development Program has increased nearly 60% since October 2015, with more than 90 proposed biosimilar products in the program.
As longstanding tensions around drug pricing and patient accessibility reach an inflection point, this long-awaited surge in activity couldn’t have come too soon. Biosimilars play a major role in solving some of the woes of the U.S. healthcare ecosystem. Healthy competition among biosimilars and reference products could lead to a wider variety of therapies and, ultimately, lower costs of care.
As we prepare for an onslaught of biosimilars, it’s critical that all healthcare stakeholders—especially manufacturers—understand how drastically the market has evolved since the first U.S. biosimilar product was launched in 2015. While seven years may not seem like a particularly lengthy time frame, several recent developments are changing the way that payers and PBMs approach biosimilars—and the way that manufacturers should approach the market.
A New World for Biosimilars
Until recently, the decision to prescribe a biosimilar product was largely left up to physicians. However, a 2016 study conducted by The Biosimilars Forum found that nearly half of providers surveyed didn’t think that a biosimilar was as safe as its reference product. This lack of understanding—and subsequent hesitancy on the part of prescribers—was a significant barrier to patient access until July 2021, when the FDA approved the insulin product Semglee as the first “interchangeable” biosimilar, deeming it able to produce the same clinical result as its reference product (Lantus, in this case).
What’s more, biosimilars that earn the interchangeable designation can be substituted for a reference product at the pharmacy counter without approval from physicians. With a slew of self-administered biosimilar products in the pipeline, this development is likely to increase patient access and bolster biosimilar adoption. Additionally, since payers typically have more control over drugs reimbursed on the pharmacy benefit, interchangeable status could result in payers quickly moving share from the biologic originators.
Another factor that has led to the biosimilar market’s recent evolution is sheer scale. With both established pharma companies and newly launched biotech startups getting in on the game—and many blockbuster biologics coming off patent—we’re seeing biosimilars expand into a wide range of therapeutic areas. This influx is happening most notably within immunology, where Humira will no longer be able to delay the market of approved biosimilars; at least eight biosimilar versions of the world’s best-selling drug are preparing to launch in 2023. Plus, the FDA has approved a second drug with interchangeable status—the Humira biosimilar Cyltezo—making it clear that stiff market competition within immunology is on the horizon.
This new landscape—a much more crowded market, changing dynamics among prescribers and payers—is a stark one, especially for biosimilar manufacturers within the immunology space. However, those that stay abreast of the rapidly changing dynamics and act accordingly will find themselves in much more hospitable territory.
Rethinking the Road Map
As we prepare to see the queue of Humira biosimilars launch in rapid succession, manufacturers are likely to turn to Remicade—the only other drug in the immunology space that faces steep biosimilar competition—for guidance on how to steer their own commercial ships. However, while understanding how these biosimilars came to market is important—critical, even—these products were launched in a much different biosimilars market.
While many may be tempted to assume that payers will take the same approach with Humira’s biosimilars as they did with Remicade’s, manufacturers need an understanding of the commercial landscape that’s grounded in today’s reality. Instead of following the Remicade road map, pharma companies—both those entering the biosimilars arena and those already in it—need to make decisions based on insights that are relevant to a more robust, increasingly complex landscape.
Will your biosimilar need to compete against others that have interchangeability status? How might multiple products impact category management? Are payers expected to review each product as it launches and make immediate changes to formulary, or will they wait to review multiple biosimilars at once? How have payers’ expectations changed when it comes to discounting?
The long-awaited biosimilars boom holds many promising opportunities for pharma, providers and patients alike. Manufacturers who avoid over-relying on historical precedence will find themselves ahead of the now sizeable competition and help pave the way for a pharmaceutical market that’s more accessible for all.
