Spectrum, Viropro to develop biosimilar

IRVINE, Calif. — A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

Spectrum Pharmaceuticals announced Wednesday a deal with Viropro to develop a biosimilar rituximab, marketed under the brand name Rituxan by Roche’s Genentech division. Global sales of rituximab in 2009 were $5.6 billion, according to Spectrum.

“We are excited at the opportunity to develop our own proprietary biosimilar formulation of rituximab in anticipation of patent expirations for rituximab over the coming years,” Spectrum CEO Rajesh Shrotriya said.

The healthcare-reform bill, which President Barack Obama signed into law in 2010, created a regulatory approval pathway for biosimilars, also known as follow-on biologics, and some analysts expected the Food and Drug Administration to have draft regulations written by the end of this year, though it may take a few years before final regulations appear.