Apotex Requests Supreme Court to Review Six-Month Notice for Biosimilars

Apotex is asking the Supreme Court to reverse a federal appeals court ruling that says biosimilar makers must give reference product holders six months’ notice before going to market.

The company is requesting that the high court decide whether the 180-day notice is mandatory under the terms of the Biologics Price Competition and Innovation Act.

In July, U.S. Court of Appeals for the Federal Circuit ruled that Apotex erred in assuming the notification requirements under the BPCIA were optional and dependent on the information exchanges.