Large Molecule

Sandoz Can Sell First U.S. Biosimilar on September 2

Source: WSJ

Jul 24, 2015

A federal appeals court ruled that Novartis' Sandoz can begin selling the first biosimilar in the U.S. on Sept. 2, 2015.

Sandoz has been locked in a court battle over selling its Zarxio treatment -- a biosimilar version of Amgen's best-selling Neupogen.

The court battle has involved complex interpretation of the Biologics Price Competition and Innovation Act. A key issue disputed was was whether Sandoz was required to provide Amgen with a complete copy of its biosimilar application.

Court rulings thus far have indicated that brand-name drug makers will be far less able to delay biosimilars through court procedures while they search for patent infringements.

Read the WSJ blog