The US FDA's Oncologic Drugs Advisory Committee will convene March 29 to assess the acceptability of Genentech Inc.’s pharmacokinetic bridging development program for its subcutaneously administered monoclonal antibody rituximab – a discussion that could have implications for biosimilars as well as the oncology market.
Rituximab was initially approved by FDA in 1997 in intravenous form under the brand name Rituxan, and is indicated for the treatment of Non-Hodgkin’s lymphoma – including follicular lymphoma and diffuse large B-cell lymphoma – chronic lymphocytic leukemia,