Change comes at a price. While there is little doubt that biologics have changed the landscape of therapy in rheumatic diseases, they have also raised the costs of healthcare in the process.
“If my patients are doing better, I give them the drug,” said Edward Keystone, MD, professor of medicine at the University of Toronto, Canada. “The fact is: patients perform better on biologics. I let the economics people worry about costs, but there’s no question we need less costly interventions.”
One solution, proposed by Dr Keystone at the 2015 annual Congress of Clinical Rheumatology, may seem paradoxical at first—starting patients with early rheumatoid arthritis on both methotrexate and a biologic.
“Even though it costs a fortune to start both at the same time early and most payers don’t pay for it,” he said, “if you can reduce the dose or withdraw the biologic, then there’s no reason why one shouldn’t consider starting methotrexate and a biologic.”
As Dr Keystone explained, biologic-free remission is possible in 40% to 60% of patients initiating a biologic plus methotrexate in early rheumatoid arthritis. And for patients who have an inadequate response to methotrexate, although biologic-free remission is infrequent, biologic dose reduction is still possible in 60% to 80% of patients who achieve a stable low disease activity state. However, drug-free remission, which means the withdrawal of all therapies, remains unlikely for either group.
“I’m personally interested in biologic-free remission,” he said. “Drug-free remission isn’t going to happen. Maybe in early rheumatoid arthritis, but post methotrexate, it’s not happening.”
Biosimilars Are Not Generics
Unlike generics, biosimilars are not chemically made, and because they are manufactured living products, they cannot be fully characterized. While the ingredients are highly similar to biopharmaceutical products already approved by a regulatory agent, they are not, in fact, the same.
“Even though the amino acid structure is identical,” Dr Keystone explained, “the carbohydrates are not the same, and this can make a difference in terms of function and sustainability, theoretically.”
Perhaps it is true in theory but not yet in practice, as indicated by recent clinical data. In the 30-week PLANETRA study, biosimilars displayed nearly identical immunogenicity as biologics. The percentage of patients with antidrug antibodies was virtually the same by the end of the trial (48.4% vs 48.3%).1
This notion of identity is critical for prescribers and payers alike. According to the US Food and Drug Administration, if a biosimilar is determined to be “interchangeable,” a pharmacist would be allowed to substitute the biosimilar for a prescribed biologic therapy without involving the prescribing physician.
There are other concerns for clinicians, as well. While Dr Keystone was convinced that biosimilars would provide the same patient support programs as the original biologics, he remained uncertain with respect to the question of sustainability.
“I have no idea whether biosimilars will have the same sustainability as biopharmaceuticals,” he said. “That’s what we worry about most [as clinicians]. We worry about sustainability.”
Based on economic forecasts, Dr Keystone estimated that the availability of biosimilars could reduce the high cost of targeted therapies for patients in the United States by as much as 35%. In Norway and India, for example, the presence of biosimilars in the market reduced costs by more than 70%.
With the exception of Norway, however, Dr Keystone speculated that it was unlikely these savings would be passed on to consumers.
“How many insurance companies when they have to pay less say, ‘we’re going to distribute wealth?’” he asked, rhetorically. “Of course [insurance companies] are going to keep the profits. They’ll make more money and it won’t be distributed any differently than it was before.”
Of equal concern for Dr Keystone was the possible impact on funding for innovative therapy, that is, diminished profits could affect Big Pharma’s investments in future drug discovery.
“If prices [for drugs] go down, then profits go down,” he said, “and if profits go down, that means you don’t have the same money for creating originator products.”
Despite these concerns, Dr Keystone viewed the transition to biosimilars as inevitable, citing the planned release of 3 biosimilar products—etanercept, adalimumab, and rituximab—by Samsung Bioepis as evidence of their arrival.
“In the next 10 years, biosimilars are going to take the market in many of the products we see today,” he concluded. “Biosimilars are here to stay, so get used to it.”
- Yoo DH. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study. Ann Rheum Dis. 2013;72(10):1613-1620.