Barriers to Biosimilars in the US

Barriers to biosimilars

Despite the benefits of biosimilars, they can be hard to get in the U.S.

The FDA has approved 45 biosimilars so far — but that number could be higher. In Europe, 76 biosimilars have been approved for use. Arguments over patents between biologic drug makers and the biosimilar producers have slowed down the introduction of biosimilars here.

And when biosimilars do make it to the U.S., insurance won’t always cover them. Even though health plans usually don’t want to pay for more expensive treatments if a cheaper one is available, pharmacy benefit managers (PBMs) sometimes incentivize health plans to get money back when they cover higher-cost drugs. Without that same type of incentive to cover the lower-cost biosimilars, insurers may be less likely to add them to covered drug lists.

Not all healthcare providers (HCPs) will even prescribe biosimilars. Though one survey showed that 9 out of 10 oncologists said they feel comfortable prescribing FDA-approved biosimilars, not all do. Five percent said they would only prescribe them based on clinical trial data, which isn't always available.

Another barrier may be that many people don’t understand what biosimilars are. Sheldon remembers when the first biosimilars were offered in the U.S. in 2015. Patients wanted to know whether the new products were safe and whether they would work. Those are still patients’ biggest concerns, she said.

“I’ve been talking about biosimilars and biologics for nine or 10 years now,” Sheldon said. “All [patients] want to know, ‘Is it going to work for me? Is it going help treat my disease, my problem, my issues?’”

Taken together, all of these barriers can make it hard to get access to these less expensive biosimilars, even though individual people and the healthcare system overall could both save money with easier access.

Patients pay the price for lack of access to biosimilars

Even when biosimilar products are covered by insurance, patients can still be on the hook for 20% of the cost through copayments or coinsurance. And those charges could cost people several thousands of dollars per month or more. For many Americans, that’s just too much.

Sheldon said she’s concerned about costs blocking fair access to treatment, particularly for people with lower incomes or people with less generous health insurance plans.

“I think we have an obligation as a society and as healthcare providers to make sure that we’re [offering] the most cost-effective and effective treatments for people,” she said. According to Sheldon, it doesn’t just affect the individual when people can’t get less expensive biosimilars. Society also pays the price because we’re missing out on the chance to curb overall healthcare costs.

Sheldon argued that health plans should cover biosimilars to help lower the overall cost of care and reduce financial burdens on patients and the system.

Opening access to biosimilars

The government is trying to make it easier for patients to get biosimilars.

In 2010, Congress passed the Biologics Price Competition and Innovation Act to lower spending on biologics and make the path to biosimilar approvals shorter. More recently, a 2021 Executive Order on Promoting Competition in the American Economy directed the federal government to expand access to generic and biosimilar drugs.

The Inflation Reduction Act (IRA), which became law in 2022, temporarily increases financial incentives to prescribe certain biosimilars administered in clinics or HCP offices. This act does not lower patient copayments, though. Its goal is to encourage HCPs to prescribe biosimilars, when appropriate.

There’s also a new bill, Increasing Access to Biosimilars, introduced in the U.S. House of Representatives in 2023, making its way through the lawmaking process.

These developments are encouraging to Sheldon.

“There’s an opportunity here for biosimilars,” she said. “[People] should be able to have access to biosimilars to save their overall cost of care and their out-of-pocket expenses.”

To gain access to biosimilars for yourself or a loved one, there are strategies that may improve your chances of getting them, according to Michele Mosier, PharmD, founder of Hope Health Advocacy.

“Educate yourself on biosimilars and their safety and efficacy. Being well-informed empowers you to engage in meaningful conversations with healthcare providers,” Mosier said. “Open communication fosters collaborative decision-making for the most effective treatment plan.”

More broadly, she encourages patients to speak up. You might help more people than just yourself if you do.

“Join patient advocacy groups and forums to share experiences and insights on biosimilar use,” Mosier said. “A united patient voice can drive awareness and policies supporting broader biosimilar access.”

This educational resource was created with support from Sandoz.