Biosimilars Council: Statute Does Not Grant Extra Six-Month Exclusivity for Biologics

February 27, 2017

The Biosimilars Council is arguing that the federal law governing biosimilars does not grant branded biologics an extra six months of exclusivity.

In an amicus brief to the Supreme Court, the Biosimilars Council contends that the Federal Circuit erred in ruling that biosimilar makers must wait six months after an FDA approval to market their products. The council filed the amicus brief in support of Sandoz, which is appealing a decision from the U.S. Court of Appeals for the Federal Circuit that said biosimilar makers must wait six months after receiving FDA approval to launch a product.

The Biologics Price Competition and Innovation Act (BPCIA) explicitly grants biologics 12 years of exclusivity and requires that biosimilar maker give at least a 180-day notice before launching their products, the Biosimilars Council, a division of the generics association, said.

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