FDA Rejects Rituximab Biosimilar’s Application

The U.S. Food and Drug Administration (FDA) has decided against approving the biologics license application (BLA) for GP2013, a proposed rituximab biosimilar.

Sandoz, the biosimilar’s manufacturer, submitted its BLA for GP2013 to the FDA in September 2017. The applications was supported by data from the ASSIST-FL trial, which compared the safety, efficacy, and pharmacokinetics of GP2013 and rituximab. Results from the multinational, double-blind, randomized, controlled, confirmatory, phase III study showed that rituximab and GP2013 performed similarly among 629 patients with untreated, advanced follicular lymphoma.

However, the FDA did not find these results robust enough to recommend approval. In response to the agency’s decision, Sandoz issued the following statement: “[Our company] stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with [the] FDA in order to bring this important medicine to U.S. patients as soon as possible.”

In June 2017, the Sandoz biosimilar received approval from the European Commission for all indications of its rituximab reference product, including non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Source: Sandoz press release, May 2, 2018.