A March 9 draft guidance from the FDA proposes an allowance for biosimilar sponsors to use clinical data from outside the U.S. to seek the agency’s approval, which would reduce the requirement of at least one study in the approval process.
Current FDA guidance requires drugmakers to conduct at least one pharmacokinetic study that directly compares a biosimilar to its biologic using a U.S.-licensed product. Pharmacokinetic studies assess how a drug is absorbed, metabolized and interacts in the body.
The guidance proposes removing a requirement of a three-way study of the proposed biosimilar, the U.S.-licensed reference biologic and a foreign comparator.
If the draft guidance is finalized, a pharmacokinetic study “can use a comparator product approved outside the U.S. if scientifically justified,” the FDA said in a March 9 statement.
“This change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs,” according to the FDA.
The proposal builds on another draft guidance for biosimilar approvals the agency published in October, which seeks to eliminate requirements for routine comparative efficacy studies and allows developers to rely more on analytical testing than clinical trials.
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