Prime Therapeutics encourages regulators to finalize biosimilar standards

Following FDA approval of Celltrion’s biosimilar to Janssen’s infliximab, Prime Therapeutics LLC issued a statement noting it remains “cautiously optimistic” about the future of biosimilar agents in the United States and urged regulators to finalize decisions on their use.

“Inflectra’s approval comes more than a year after the first biosimilar was approved in the [United States] U.S.,” David Lassen, chief clinical officer for Prime, said in a company press release. “If approvals continue to be this slow, it will be many years for biosimilars to have an impact on high drug prices. Americans cannot afford to wait and more needs to be done to slow the unsustainable growth in drug costs.”

In the release, Prime representatives also wrote, “Significant issues still remain with regard to interchangeability, and naming still needs to be finalized. Until these are resolved manufacturers may be reluctant to bring more biosimilars to market. Prime encourages regulators and the FDA to speed up approvals and finalize their decisions on this complex and influential issue in our industry.”

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