Amgen v Sandoz: The biosimilars saga continues

Sandoz’s launch of Zarxio (filgrastim-sndz) on September 3 began a new phase in the continuing biosimilars saga. It was the first biosimilar product to be licensed under the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA permits a biosimilar drug applicant (known as a section 262[k] applicant) to rely on the safety, purity, and potency data of a reference product already approved by a more stringent process required for innovator products. Zarxio has successfully navigated the BPCIA’s abbreviated, though convoluted, path to market and a number of additional biosimilar products are in the approval pipeline.