Biosimilar Rheumatology Roundup: April 2019

This month saw steps forward for biosimilars in the rheumatology space, with product approvals in multiple markets and the publication of long-term data that support the use of biosimilar agents in treating inflammatory diseases.

Perhaps the biggest news in rheumatology biosimilars this month was the FDA’s approval of Samsung Bioepis’ Eticovo, a biosimilar etanercept referencing Enbrel. The product, etanercept-ykro, was approved to treat all indications of its reference, and joins Sandoz’s Erelzi in the lineup of approved etanercept biosimilars. However, Erelzi has not yet launched; Sandoz has been embroiled in a legal battle with Amgen, maker of the reference drug, in a long-running dispute over patents, and it remains to be seen which biosimilar will be first to reach US patients.

Eticovo is already approved in a variety of other markets, including the European Union, Canada, Australia, and elsewhere, under the brand names Brenzys and Benepali, and Samsung Bioepis earned $124 million in sales from the drug in the first quarter of 2019, according to Biogen’s financial report.

Biogen, which together with its partner Samsung BioLogics forms Samsung Bioepis, also reported an impressive $36 million in revenue from its biosimilar adalimumab, Imraldi, which has been demonstrating strong sales in the European marketplace.

Those sales are bad news for AbbVie, maker of the reference adalimumab, Humira; in its own earnings report, AbbVie said that it saw its net international revenues drop by 27.9% on a reported basis, which the company says was a result of biosimilar competition. US Humira revenue grew by 7.1% last quarter to $2.315 billion, as the company still faces no US biosimilar competitors, but worldwide net revenues for Humira dropped by 5.6% on a reported basis.

The range of adalimumab options also increased in the European Union this month, as the European Commission granted a marketing authorization for yet another biosimilar: Fresenius Kabi’s Idacio. Per the terms of its October 2018 settlement with AbbVie, Fresenius Kabi was permitted to launch Idacio in the EU marketplace immediately, but the drug maker will pay AbbVie royalties on sales.

Canada also saw a landmark approval this month when regulators granted an authorization to biosimilar rituximab, Truxima, for indications including rheumatoid arthritis (RA). While the same biosimilar was recently approved in the United States, due to patent exclusivity issues, the biosimilar was only approved by the FDA for oncology indications.

April wasn’t only a busy month for regulatory action on biosimilars; it also saw the publication and presentation of a number of studies that add to the body of literature on the safety and efficacy of biosimilars.

Amgen’s biosimilar adalimumab, which is not yet launched in the United States but is sold in the European Union as Amgevita, got a boost from the results of an open-label extension study of its phase 3 trial in patients with RA up to 72 weeks. The researchers reported that efficacy was maintained and safety was consistent with the known adalimumab profile in patients who took the biosimilar continuously as well as in those who switched to the biosimilar from the reference.

Another long-term study, with results up to week 54, was reported for a biosimilar infliximab: Sandoz’s EU-authorized Zessly. Researchers reported that American College of Rheumatology response rates for RA, disease activity scores, changes in the Health Assessment Questionnaire-Disability Index, and the incidence of anti-drug antibodies were similar among patients who took the biosimilar, those who took the reference, and those who switched from the reference to the biosimilar.

This month also saw the presentation of real-world data on biosimilar infliximab agents during the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA). Among the findings reported were that drug retention rates for biosimilar infliximab Inflectra were comparable with those of the reference Remicade among patients with RA.

Also at the APLAR-ARA meeting, research teams reported that patients with spondyloarthritis were effectively treated with biosimilars, leading to disease remission and improved quality of life.

Finally, this month saw signs of increasing biosimilar uptake in the United States; pharmacy benefit manager Magellan Rx Management reported that its utilization management initiative, which focuses on Inflectra, has allowed health plans that implemented a “comprehensive management approach” to achieve up to 86% biosimilar use. Health plans that took a “softer approach,” under which only new patients are asked to use the biosimilar agent instead of the brand-name Remicade, have seen their biosimilar use climb to as high as 75%.