Sandoz Abandons Its US Biosimilar Rituximab Plans

Sandoz announced on Friday that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.

Sandoz announced on Friday that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.

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.” Hendricks added that Sandoz would now focus on the biosimilars in its pipeline that “can best meet rapidly evolving patient and healthcare system needs.”

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 the brand-name Rituxan.

While the FDA had requested additional data from Sandoz on the product, the biosimilar has been approved in the European Union since June 2017, where it is sold as Rixathon. The data package leading to European authorization included data from the ASSIST-RA study, which demonstrated equivalent pharmacokinetic and pharmacodynamic profiles of the biosimilar and its reference, with no clinically meaningful differences in safety, tolerability, or immunogenicity in patients with rheumatoid arthritis (RA). Also included were data from the ASSIST-FL study, a phase 3 confirmatory study in which the biosimilar and its reference showed equivalent overall response rate and comparable safety at 6 months in patients with follicular lymphoma.

Further data from a randomized, double-blind, parallel-group study conducted at 28 centers in the United States and 26 centers in the European Union has demonstrated that switching to the biosimilar from the reference rituximab is safe in patients with active RA.

Sandoz’s change of course means that there will likely be only 1 biosimilar rituximab product available to US patients in the foreseeable future; Celltrion’s CT-P10 recently received a unanimous recommendation from the FDA’s Oncologic Drugs Advisory Committee and is awaiting a final regulatory approval.

However, Celltrion, because of issues related to patents on the originator drug, is only seeking FDA approval for the treatment of non-Hodgkin lymphoma, and is not seeking any indication for the treatment of inflammatory diseases such as RA.