Biosimilar Developers Must Scale Mountains of Data

By Rebecca Stauffer and Walter Morris, PDA

Powerful Analytics, Strong Science Permit Biosimilars

The U.S. FDA approved Sandoz’s filgrastim product, Zarxio, a biosimilar of Amgen’s Neupogen. This was a big step for the Agency, and one some feel was long in coming. The same product was approved for marketing in Europe six years earlier (under the name Zarzio). Incidentally, the following year, the Biologics Price Competition and Innovation Act (BPCIA) was signed into law in the United States, which was seen as opening the gateway for biosimilars in the United States