In April of 2016 the FDA approved a new biosimilar to infliximab (Remicade), called Inflectra. This was the very first monoclonal antibody biosimilar, and since then an additional two biosimilars have also received approval. They are Amjevita, which is a biosimilar to adalimumab (Humira), and Erelzi, which is a biosimilar for etanercept (Enbrel).
The American College of Rheumatology (ACR) released a statement in April, indicating that the FDA classifies products as ‘biosimilar’ if they have been seen to lack any clinically meaningful differences in respect to ‘safety, potency, and purity’. At the time Inflectra was approved, Douglas White, MD, PhD, a spokesman for the ACR’s Committee on Rheumatologic Care, indicated that it was the hope of the ARC that biosimilars would prove helpful in reducing the cost of biologics, and as a consequence improve access to complex and lifesaving drugs for patients who desperately need them.
More recently, White has furthered this by stating that they remain ‘cautiously optimistic’ concerning biosimilars, including Inflectra. White pointed out that, since April, the most vital development has been the release of results from NOR-SWITCH, who conducted a trial into the maintenance of efficacy, and adverse events after patients were not given any medical indication that they should change drugs. Patients who did change were previously using the biosimilar infliximab, to treat their psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, spondyloarthritis, psoriasis, or ulcerative colitis.
This study was presented during a late-breaker session in the ACR meeting. Patients were followed for a year after their medication was switched from reference infliximab, to the biosimilar CT-P13, with some patients remaining on infliximab as a control. The results indicated that the disease worsened in 26.2% and 29.6% cases, respectively, which is within the margins of non-inferiority.
White stated that he was disappointed there was no indication that the availability of biosimilars had been impactful on patient expenses. In addition, he noted that there was no evidence to indicate that the availability of biosimilars would reduce the cost of patient insurance premiums, with pricing indications showing only a moderate reduction in costs.
Despite this, White remains hopeful that this situation will change once the currently unresolved issues with biosimilars – including the FDA’s final decision concerning state laws and regulations on interchangeability – have been settled. At present, the three rheumatology biosimilars which have been approved do not possess interchangeable status. Once this changes, the impact on patient costs and insurance premiums may improve.
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