Health officials announced on Oct. 29 that they are proposing the elimination of testing requirements for biosimilars, or generic versions of biologic drugs.
The Food and Drug Administration in draft guidance said it will reduce instances where large human trials are required for biosimilars.
If a comparative analytical assessment shows that a biosimilar is similar to a biologic, then a comparative efficacy study “may not be necessary,” the guidance states.
“We’re cutting unnecessary red tape, reducing uncertainty, and making it easier for innovators to bring safe, affordable biosimilars to the market,” Health Secretary Robert F. Kennedy Jr., whose Department of Health and Human Services includes the FDA, said at a news conference in Washington….