Biosimilar Rheumatology Roundup: November

November saw a number of developments related to biosimilar therapies for rheumatologic indications, with new data published, policies adapted, and devices launched.

Biosimilars Took Center Stage at ACR’s 2017 Meeting

At this month’s American College of Rheumatology’s (ACR) 2017 annual meeting in San Diego, California, biosimilars were the focus of an intense debate over the merits of non-medical switching, and research presented at the conference pointed to some potential pitfalls in switching patients from reference therapies to cheaper biosimilars. Rheumatologists grappled with the challenges of using biosimilars in their practices, and researchers presented new data on proposed etanercept and adalimumab biosimilars.

Patient-Friendly Devices Gain Momentum

Reference product sponsors may be trying to differentiate their products from biosimilar competitors by launching innovative devices; this month, Amgen launched an ergonomically designed cartridge with a reusable auto-injector for its US-licensed etanercept, Enbrel. Meanwhile, Takeda announced that it is developing a needle-free delivery device for its biologics.

Newly Approved Biologics Assigned Suffixes

The FDA implemented a regulation for the naming of biological products; the agency began assigning newly approved innovator biologics 4-letter suffixes, devoid of meaning, that are appended to their nonproprietary names. While some stakeholders have challenged the utility of such suffixes, a survey of Canadian physicians found that prescribers overwhelmingly supported the use of distinguishable names for all biologics and biosimilars.

Changes to Biosimilar Reimbursement

CMS announced a major change to its biosimilar reimbursement policy, saying that it would, beginning in January 2018, assign each biosimilar its own reimbursement code. Current policy, which groups all biosimilars for a single reference under 1 code, had been criticized by stakeholders who felt that price competition was stifled by the policy.

CMS also suggested a second change to the way it addresses biosimilars. The agency’s new proposed rule would expand the definition of generic drugs under Medicare Part D for cost-sharing purposes. ACR praised the proposed rule, saying that lower-cost options could encourage enrollees to choose biosimilar products and therefore reduce costs to Medicare.

European Patients Get New Educational Materials

The European Commission (EC) and the United Kingdom’s National Health Service (NHS) both took steps to improve the education that patients receive about biosimilar therapies. The EC launched a patient-education document, “What I Need to Know About Biosimilar Medicines,” which answers commonly asked questions about these therapies, in 23 EU languages. Meanwhile, the NHS introduced a new website, “Focus on Biosimilars,” that addresses the ways in which biosimilars can benefit the NHS and educates patients about switching programs and clinical trials.

European patients also have a new biosimilar adalimumab on the horizon; the EC granted a marketing authorization to Boehringer Ingelheim’s (BI) Cyltezo, referenced on Humira. It is unclear when the drug—also approved by the FDA—will become available, however, as BI is engaged in ongoing patent litigation with AbbVie.

Europe did gain certainty in another area this month, however: after a contentious vote by European Ministers, the EMA will be moving to Amsterdam, Netherlands. The agency, which is currently located in London, United Kingdom, will relocate to the Dutch city in order to keep its operations within the European Union after Brexit.