Sandoz announced that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.
In May 2018, Sandoz announced that it had received a Complete Response Letter from the FDA for the proposed biosimilar. Sandoz had sought FDA approval for all indications of Genentech’s rheumatoid arthritis med, Rituxan.
According to a statement from Stefan Hendriks, global head of biopharmaceuticals at Sandoz, "We appreciate the important conversations with the FDA, which have provided specific requirements for our potential US biosimilar rituximab, but believe the patient and marketplace needs in the [United States] will be satisfied before we can generate the data required.”
The biosimilar rituximab is already approved in EU, Switzerland, Japan and Australia. Sandoz’s change of plans means there will most likely only be one biosimilar rituximab product available to U.S. patients: Celltrion’s CT-P10 recently received a unanimous recommendation from the FDA’s Oncologic Drugs Advisory Committee and is awaiting a final regulatory approval.
Read the press release