Biosimilar Rheumatology Roundup: June 2018

The Center for Biosimilars Staff

This month saw a variety of developments in the world of biosimilar drugs for the treatment of rheumatic diseases.

This month saw a variety of developments in the world of biosimilar drugs for the treatment of rheumatic diseases.

First, 2 more biosimilars for the treatment of inflammatory disease have received positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). Pfizer announced a positive CHMP opinion for its first European anticancer biosimilar, a trastuzumab product that the company plans to sell as Trazimera, and Sandoz announced a positive CHMP opinion for its adalimumab biosimilar, GP2017. Sandoz plans to market its drug under 3 names: Halimatoz, Hefiya, and Hyrimoz. Both molecules will now be will now be reviewed by the European Commission for final authorization.

This month also saw new research presented at the European League Against Rheumatism (EULAR)'s Annual European Congress of Rheumatology, held from June 13 to 16 in Amsterdam, Netherlands. The patient experience with switching to biosimilars was a key area of interest, and research presented during the meeting showed that, among patients who receive education, many are open to switching; 75.4% of Australian patients in a cross-sectional study said that they would accept a switch if it was recommended by their rheumatologist, and among Dutch patients who switched to a biosimilar and received coordinated communication about the process, zero patients reported that the information they received was inadequate to their needs.

The EULAR congress also featured data from switching studies that supported the feasibility of switching patients to biosimilars of etanercept (Enbrel), and a study of a switch to biosimilar infliximab in patients with Behçet disease showed, contrary to a recent case study, that a switch is not associated with a rapid loss of response.

Additional research showed that, as expected, a nonmedical switch to an infliximab biosimilar brought down costs; investigators from Lisbon, Portugal, said that a switch of patients in a single center brought down costs of infliximab treatment by 26.4%. However, another study found that nonmedical switches may increase overall healthcare utilization.

Cost effectiveness is a key concern in treating inflammatory diseases. New research demonstrates that, among patients with rheumatoid arthritis (RA) who do not respond adequately to the anti—tumor necrosis factor (anti-TNF) agents with which they initiate treatment, switching—or “cycling”—to alternative anti-TNF products is common, but it’s also costly. The study suggests that using tofacitinib, an oral Janus kinase inhibitor, as second-line treatment after methotrexate could be a more cost-effective approach than initiating and cycling anti-TNF therapies.

Among anti-CD20 drugs that present an option for treating RA that has proven to be refractory to other agents, rituximab has previously been shown to be effective at doses of 1000 mg. However, 2 separate studies presented at EULAR demonstrated that using low doses (600 mg) and ultra-low doses (100 mg) of biosimilar rituximab is effective in patients with treatment-refractory RA.

Despite progress in developing such new therapeutic approaches, studies from Europe and the United States showed that patients with RA are staying on ineffective treatments for too long. A Polish study found that 50% to 70% of patients remained on an ineffective treatment for an inappropriate length of time, and a US study, using the Corrona registry, found that 64.5% of patients continued to receive an ineffective therapy at 12 months after initiation.