As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade, the generic and biosim specialist sees a multibillion-dollar opportunity up for grabs.
The company detailed its outlook on the upcoming “‘golden decade’ of affordable medicines” at the J.P. Morgan Healthcare Conference last week. Tallying up expected losses of exclusivity across the industry over that period, the Swiss drugmaker sees a generic drug opportunity of up to $340 billion and a biosim opportunity totaling $322 billion.
More than 50 biologic drugs are set to go off patent in the next seven years and have no biosimilars lined up to launch. This situation has created what’s been coined the “biosimilar void” among industry watchers.
While fully dissipating the void will require participation from many biosim players, Sandoz is committed to the cause: The company boasts a plan to target some 60% of the total biosimilar opportunity in sight.
Still, “we want to do more,” the company’s North American president, Keren Haruvi, told Fierce Pharma in an interview on the sidelines of JPM.
Haruvi, who also chairs the Association for Accessible Medicines, credits Sandoz with years of advocating for regulatory changes related to biosimilars. These efforts manifested last year with the FDA’s revised guidance on the copycat biologic drugs.
The draft guidance is meant to streamline biosimilar drug development by reducing the need for additional trials, allowing companies to develop biosimilars more quickly and for about half the cost, she explained. While the proposed regulations are still in the draft guidance phase, Haruvi is “very optimistic” that they'll be implemented as part of final agency guidance.
U.S.-specific challenges
Despite the progress on the regulatory front, the U.S. biosimilar market still has a long way to go to deliver on its cost-savings potential.
“I’m not happy,” Haruvi said when asked about the state of U.S. biosimilar access today.
“The promise of biosimilars in the U.S. is not what it should be,” she said, adding, “it’s disappointing.”
As she puts it, the unique dynamics in the U.S. healthcare system make it the “toughest market in the world” for biosims. Yet, it’s still one Sandoz knows how to navigate.
Having launched the U.S.’s first biosimilar in 2015, Sandoz is well-versed on the driving factors behind successful U.S. biosimilar launches. For example, the company’s copy of AbbVie’s immunology blockbuster Humira, called Hyrimoz, is “by far the most successful” copy in the crowded market, Haruvi said.
Haruvi attributes Hyrimoz’ success in part to the foundational necessity of a reliable supply, without which “you have no chance to win,” she said. But to really lead the pack, the key is to have a finger on the pulse of market dynamics. This is how Sandoz ended up at the forefront of a now-dominant biosimilar market strategy in 2023, when it formed an alliance with CVS Health’s biosimilar arm Cordavis.
Hyrimoz’s early spot on CVS formularies immediately spiked sales and allowed the drug to capture significant market share. Now, private-label relationships between pharmacy benefit managers (PBMs) and biosimilar makers are a common tactic.
“In the U.S., you have a lot of people in the channel that you need to incentivize, and that's the challenge at the end of the day,” the executive explained. But as it stands, some stakeholders in the healthcare system are often focused on “looking at their own profits versus what the savings could be,” she said.
Haruvi pushes back on the idea that patient preference has any say in the matter, a factor that has been occasionally linked to low biosimilar adoption.
“The patient, unfortunately, is not the one to decide,” she emphasized. “I think patients would prefer lower costs.”
The burden instead lies in educating consumers about the world of biosimilars, something that Haruvi thinks would be fruitful given that most are already “very comfortable” with generic drugs.
For his part, Teva’s CEO Richard Francis points out that for biosimilars, adoption isn’t as simple as “you launch and people will come.”
“That’s not how it works,” he said in a separate interview at JPM.
“You have to understand the channel, the PBMs, the payers, private labels, the very fragmented healthcare system in the United States,” Francis explained, adding that he remains “very optimistic” about U.S. biosimilar growth trajectory.
Biocon Biologics’ CEO Shreehas Tambe has an optimistic stance as well. Tambe spoke with Fierce on the sidelines of JPM after the drugmaker recently announced its plans to integrate Biocon Biologics into its larger company later this year, buying out stakeholders such as Viatris to make the biologics firm wholly owned.
In making his case for optimism, the exec cited a previous expectation held by many in the industry that the U.S. “will never accept or approve a biosimilar.” Now, though, the FDA is signing off on biosims at “a faster rate than any other regulators in the world,” he said.
Although he admits that the U.S. market “takes time” to crack, he argues that due to the need that cheaper biosimilars can fill, adoption of the drugs can be “very high” upon ensuring proper quality and supply.
“Everyone is looking to bring the costs of medications down, and I think it's not lost on anybody that biosimilars are a part of that solution,” he said.
Standalone Sandoz
After splitting from Novartis in 2023, Sandoz is unique in being a standalone biosimilar and generics company with global reach.
Branching out from its parent company gave Sandoz the chance to be “much bolder” in advocating for biosimilars and generics in a way that’s often not possible under an innovative drugmaker, Haruvi said.
A major focus of innovative companies revolves around extending the life spans of their branded drugs, while biosim players view these patent cliffs as opportunities and look to launch their products as soon as possible.
At the end of the day, “the products are not that different,” Haruvi said, referring to the very nature of biosimilar drugs. What makes a difference, however, is the company behind the product. As for Sandoz, “there is no one like us,” she said.