High Court Refuses to Hear Case on Six-Month Wait for Biosimilar Launch

The U.S. Supreme Court has refused to hear a case on whether biosimilar makers must wait six months after receiving FDA approval to bring a product to market.

The high court denied a petition from Apotex to overturn a federal appeals court ruling that that says biosimilar makers must give reference product holders six months’ notice before going to market. This particular case involves the launch of a biosimilar version of Amgen's Neulasta.

The refusal lets stand a Federal Circuit decision that says the 180-day notification required by federal law must come after a company secures FDA approval.