EXPERT ANALYSIS FROM THE WINTER RHEUMATOLOGY SYMPOSIUM
SNOWMASS, COLO. (FRONTLINE MEDICAL NEWS) – If you thought biosimilars would bring sharply reduced pricing compared with their parent agents, with resultant greater patient access to highly effective therapies for rheumatic diseases … think again.
“The promise to our patients of biosimilars – greater access to treatments – is something I think we’re just not going to see, at least not here in the U.S.,” Michael E. Weinblatt, MD , declared at the Winter Rheumatology Symposium sponsored by the American College of Rheumatology.
“The difference between the U.S. and Europe in the biosimilars is not in the clinical response. In Norway, there was a 60% price reduction compared with infliximab in its biosimilar. That same molecule was approved by the FDA. It’s now available here commercially, and, if you can get a 15% price reduction, you’re doing well. It’s just remarkable, actually: We see huge price reductions in Europe and South Korea, and we’re just not seeing that in the U.S.,” according to Dr. Weinblatt, professor of medicine at Harvard Medical School, Boston.
In contrast, the safety and efficacy of the biosimilars, as well as their interchangeability with their reference products, appear to be as hoped for. At the 2016 annual meeting of the American College of Rheumatology, Dr. Weinblatt presented the week 24 results of a phase III, randomized trial involving rheumatoid arthritis patients on background methotrexate plus either adalimumab (Humira) or its biosimilar SB5.
“Essentially, they’re dead on in clinical response, they’re dead on in antibody levels, and they’re dead on in toxicity. And, you can put any of the biosimilars up there and the results are the same. If they get approved, this is what you’re going to see,” the rheumatologist said.
Also at the 2016 ACR annual meeting, he noted, Danish investigators presented reassuring 1-year follow-up data on 802 Danes with inflammatory rheumatic diseases who switched from infliximab (Remicade) to its biosimilar Remsima. Disease activity and flare rates in the year following the switch were similar to those in the year before. The 1-year rate of adherence to Remsima was 84%, similar to the historical 86% 1-year rate with infliximab.
“So, I’m pretty comfortable with the biosimilars,” Dr. Weinblatt continued.
He observed that, of all the systemic rheumatic diseases, the greatest progress has occurred in the treatment of rheumatoid arthritis.
“We have made great advances in the treatment of this disease, unlike many of our other diseases. Methotrexate and combination therapies with small molecules and biologics has dramatically changed the course of the disease,” he noted. “The greatest challenge we have now as rheumatologists is access barriers for our patients.”
Dr. Weinblatt reported receiving research grants from half a dozen companies and serving as a consultant to more than two dozen.