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The approval of biosimilars in the U.S. is lagging behind that of European countries, a pharmacist said during the American Society of Health-System Pharmacists (ASHP) Midyear virtual meeting.

While the European Medicines Agency (EMA) began approving biosimilars in 2006, the FDA did not approve its first biosimilar (filgrastim) until 2015, noted Jorge García, PharmD, MS, MHA, MBA, of Baptist Health South Florida, during his presentation.

In contrast, the EMA approved a filgrastim biosimilar in 2008.

However, in recent years, the number of biosimilars the FDA has approved has been trending upwards, García conceded. In 2019, the FDA approved 10 biosimilars. Due to the COVID-19 pandemic, approvals have since slowed down, as the FDA cannot perform in-person inspections, he explained.

Biosimilars require a different approval pathway from that of generic drugs. In 2009, the established an abbreviated approval path specifically for biosimilars.

Biosimilars can drive down the cost of medications and also promote innovation in the marketplace, García said.

As biosimilars stay on the market for more years, we have more confidence in their safety and efficacy, he added. To date, no biosimilars have been pulled from the market in Europe or the U.S.

This year, the FDA approved its first interchangeable biosimilar for insulin, meaning that pharmacies can substitute the reference drug with its biosimilar without a prescription from a physician.

As insulin prices have been increasing at a faster rate in the U.S., having a biosimilar option is an important development, García said. However, more interchangeability designations by the FDA are "going to come later rather than sooner."

While approvals are increasing, there are also market barriers for biosimilars, he noted. For example, the six biosimilars for adalimumab (Humira) that the FDA has approved since 2016 can't enter the market until 2023 because of patent litigation. That date could be delayed even further with future litigation, García pointed out.

In Europe, biosimilars for adalimumab have been available since 2018. "This really brings a lot of concerns about the intent of the patent law in the U.S.," he said.

By the time those biosimilars come to the market in the U.S., a different standard of care may have evolved, he explained.

There are emerging regulations in the U.S. to accelerate biosimilar introduction into the market. In Minnesota, a bill was proposed earlier this year that will broaden biosimilar choice by dictating payers cover all versions of a biologic, including its biosimilars.

In Congress, a bill was introduced in late 2020 to grant immediate interchangeability status for any insulin biosimilars that the FDA approves.

"As we move into the future, though, we really need to find more long-term sustainable pharmacoeconomics models for biosimilars," García said.

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