From the Expert: Patient Access Is Key for Biosimilars in Development to Be Effective

SB5, a biosimilar to adalimumab (the reference product), is effectively equivalent and well tolerated by patients with moderate to severe rheumatoid arthritis (RA), according to a late-breaking abstract from the 2015 ACR/ARHP Annual Meeting. The report, led by veteran rheumatologist Michael Weinblatt, MD, is a needed threshold to continue researching the efficacy of biosimilars for patients with autoimmune diseases, particularly RA.

This report “is critical because it demonstrates that companies can manufacture a biosimilar,” Dr. Weinblatt says. “The first biosimilar for rheumatoid arthritis … was recommended for approval by the U.S. FDA’s Arthritis Advisory Committee, so I think it’s just a matter of time before we see a number of these [drugs] going to the FDA and presumably getting approved.”

The study, “A Phase 3, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week Results),”¹ found that the biosimilar SB5 was “well tolerated with similar safety profile (pharmacokinetics), and immunogenicity to [adalimumab].”

Michael Weinblatt, MD

Dr. Weinblatt says he was pleased with the outcome of the study, but the next step is research that examines whether patients can safely switch between biosimilars and the originator molecules. Even if switching is deemed safe and effective, the price for these treatment therapies will need to be reduced or there will be little real progress, he adds.

“The key is accessibility of care for patients,” Dr. Weinblatt says. “That should be the driving principle. And if biosimilars lead to substantive cost reductions for our patients so that more patients can access therapy, then that is going to be a great thing. If there’s no substantive price reduction in the United States with the biosimilars, then it doesn’t add anything.

“In Europe, we have already seen substantive price reductions … [However,] because we have a complicated healthcare system, I honestly don’t know whether the promise of biosimilars from a price standpoint will be actually reflected in our patients’ being able to access therapy with lower co-pays and easier access.”

Recently, the American College of Rheumatology (ACR) released a revised position statement that updates and clarifies the ACR’s positions on extrapolation, substitution, notification and the labeling of biosimilars. Since then, the College has continued to advocate for the safe adoption of these drugs, most recently at a U.S. Food and Drug Administration public hearing in February.

Richard Quinn is a freelance writer in New Jersey.

Reference

1. Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. A phase 3, randomized, double-blind clinical study comparing SB5, an adalimumab biosimilar, with adalimumab reference product (humira) in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy (24-week results). Arthritis Rheumatol. 2015 Oct;67(s10): 1–4046. doi: 10.1002/art.39448.