Novartis subsidiary Sandoz became the first company to file for approval under the newly created US biosimilars pathway. The company is seeking the go-ahead to market biosimilar filgrastim as Zarzio, a granulocyte-colony stimulating factor, a copy of Amgen's Neupogen, indicated for nonmyeloid malignancies in patients receiving myelosuppressive anticancer drugs. Zarzio, approved in the EU since 2008, became the first biosimilar to overtake its reference product. In August, the first application for a monoclonal antibody under the US biosimilar pathway was made by South Korea's Celltrion. Remsima is a biosimilar of Janssen Biotech's original reference drug Remicade (infliximab). As part of the application, Celltrion submitted pharmacokinetic and pharmacodynamics equivalency and safety data obtained for the originator products sold in the US and EU and for Remsima. Celltrion already markets Remsima in 50 countries.

“Even if one believes the need for California to devote $3 billion to a narrow, extremely speculative field of science, the Trounson case and other CIRM [California Institute for Regenerative Medicine] administrative missteps have made clear that Proposition 71 created the wrong framework to manage a complex research effort. The initiative left the public with no way to tell if its money has been well spent, and no accountability if it hasn't.” Columnist Michael Hiltzik on the announcement that the CIRM's former president Alan Trounson accepted a seat of the board of a company that receives funds from the institute. (Los Angeles Times, 18 July 2014)