Hurdles In Access: Costly Switch Studies Block Wider Biosimilar Use


Addressing requirements around FDA interchangeability designations can increase the adoption of biosimilar substitutions at the pharmacy level.

Despite their clear benefits, regulatory issues hindering access and adoption to biosimilar therapies still persist. “The one…that stands out to me the most is that various states and payers still have not allowed pharmacist-level substitutions for biosimilars without the FDA-approved interchangeable designation,” said Lakesha Farmer, Senior Director, Strategic Accounts, ION Oncology Practice Network at Cencora.

In order to be granted interchangeable status, the FDA requires that a biosimilar agent undergo an extensive switch study, in which participants are alternated between treatment with the reference product and the biosimilar product to provide that the biosimilar is “highly similar in nature and noninferior to the reference product,” Farmer explained. The issue with these switch studies, though, is their cost: “As we know, drug studies are typically very expensive,” Farmer added. “These studies can cost millions of dollars. They can also further delay the market launch for biosimilar products.”

In July 2023, legislators introduced the Biosimilar Red Tape Elimination Act in an effort to eliminate the need for interchangeable designations by removing the switch study requirement—a requirement that only exists in the United States. Other countries, Farmer said, acknowledge all biosimilars as interchangeable on market approval: “If the interchangeability requirements are removed, this could positively impact the adoption of biosimilars and allow for automatic substitutions at the pharmacy level.” This change could lead to sustainability in the market, less expensive go to market strategies for manufacturers, and more affordable medications for both the health care system and patients.

Farmer sat down with Drug Topics at AXS24, the Asembia Specialty Pharmacy Summit, held April 28 to May 2 in Las Vegas, Nevada. Click here for more of our coverage from AXS24.

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