European Commission Approves Second Biosimilar for Cancer Treatment Rituximab

The European Commission has approved Rixathon, a biosimilar of the cancer drug rituximab, for use in Europe, according to an announcement from Novartis, whose Sandoz division manufactures the biosimilar.

In the European market, the biosimilar will now compete against the reference drug, sold by Roche as MabThera, but also another new biosimilar, Celltrion’s Truxima, which was approved by the European Medicines Agency in February 2017.

The press statement from Novartis states that Rixathon is indicated for non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as autoimmune disorders like rheumatoid arthritis (RA), granulomatosis with polyangiitis, and microscopic polyangiitis.

These indications were granted based on clinical data showing Rixathon’s pharmacokinetic and pharmacodynamic similarity to MabThera, which “demonstrated Rixathon matches its reference medicine in terms of safety, efficacy, and quality,” according to the press release. These trials included the ASSIST-RA study, which focused on patients with RA, and the ASSIST-FL study, which measured safety and overall response rate.

For European patients with these diseases, the approval of another biosimilar is likely to be heralded as good news, as it may expand access and lower prices.

"Today's approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics,” said Carol Lynch, global head of biopharmaceuticals at Sandoz, in the press statement. “It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies."

A recent study estimated that use of Truxima, assuming it costs 70% of MabThera’s price, could result in €90 million in savings annually, as well as a 6.4% increase in the number of patients accessing rituximab, as 7531 additional patients would be able to receive the drug in that year. This projection did not account for any potential market effects introduced by the approval of alternate biosimilars like Rixathon.

Presumably, Sandoz will soon seek to file an application with the FDA for US approval of Rixathon. Big Molecule Watch reported that Novartis executive Joseph Jiminez said during a January 2017 earnings call that the division is “on track” to file such an application this year, explaining that the FDA had asked “for additional progression free survival data from the phase 3 studies,” meaning that they had “to wait for that data to mature in order to provide it for the filing.”

Sandoz, the biosimilar arm of Novartis, is still riding high from last week’s Supreme Court decision ruling in favor of its ability to get biosimilars to market sooner. According to the ruling, biosimilar applicants can give the reference drug’s manufacturers the required 180-day marketing notice before receiving FDA approval. Amgen, on the losing side of the court battle, had argued that a new drug should have to be licensed before its maker gives notice, which would have awarded Amgen’s reference drug 6 extra months of market exclusivity.