Biosimilars Research

As one of Canada’s leading patient voice on biosimilars, ACE continues to monitor the ongoing research and development of biosimilar medications to provide patients the latest, unbiased, and evidence-based information on this medication treatment for inflammatory arthritis.

Latest news on biosimilars

One of the “hot topics” at the most recent American College of Rheumatology Annual Meeting and European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology was biosimilars. Based on the research data presented, it is clear that in 2016, biosimilars offer patients and rheumatologists another choice in the treatment of inflammatory arthritis.

Biosimilars data from abstracts published or presented at the annual EULAR Annual European Congress of Rheumatology meeting in London in June 2016 show that the safety and efficacy profiles for biosimilar versions of etanercept, infliximab and adalimumab were similar to the originator biologic in rheumatoid arthritis and ankylosing spondylitis patients who were transitioned from the originator biologic to the biosimilar version.

However, another study at EULAR showed that when antibodies develop in response to the biological treatment Infliximab (Remicade), they cross-reacted with the biosimilar of infliximab (Inflectra). The study’s lead authour said: “Our results have shown that all the antibodies that developed in patients being treated with Remicade cross-reacted with the biosimilar. The presence of these anti-infliximab antibodies is likely to enhance clearance of the drug from the body, potentially leading to a loss of response, as well as increasing the risk of side effects. Therefore, in patients where biological infliximab is ineffective due to the presence of circulating antibodies, switching to its biosimilar will lead to the same problems.” 

Due to limited sample size of patients and the need for further research to better understand the potentially different immune responses in arthritis patients, this study represents early stage research in the area of “switching” or “transitioning” patients from originator biologic to biosimilar. More data on “switching” and “transitioning” is expected at the American College of Rheumatology Annual Meeting in November 2016.

Post Marketing Surveillance Research
Tracking the efficacy, safety and value to patients and the health care system of both originator biologics and their biosimilars is important. Patients and their physicians rely on this "real world data" when they are making treatment decisions.

In August 2016, the Annals of Internal Medicine published a study by researchers at Johns Hopkins University and Brigham and Women’s Hospital that evaluated a series of biosimilar studies that treat inflammation for patients with rheumatoid arthritis and inflammatory bowel syndrome, called TNF-alpha inhibitors. The researchers systematically reviewed 19 studies to determine how these biosimilars compared with the originator biologics, focusing on safety and efficacy. They concluded the biosimilars are “biosimilar” and “interchangeable” with the original versions, such as infliximab (Remicade) and adalimumab (Humira).

Earlier in 2016, commenting on the Food and Drug Administration announcement on April 5, 2016 of the approval of infliximab (Inflectra), the first biosimilar to receive approval in the U.S. for the treatment of inflammatory arthritis, Joan Von Feldt, MD, MSEd, President of the American College of Rheumatology said: “The safe adoption of biosimilars into the U.S. marketplace remains a top priority for the American College of Rheumatology. Biologics are a lifeline for patients living with rheumatic disease, helping many to avoid pain, long-term disability, and life-threatening complications. Unfortunately, many of our patients struggle to afford these complex therapies due to their high cost. The ACR welcomes the introduction of biosimilars to the U.S. healthcare system and is hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars in the U.S. will increase our patients’ access to life-changing therapies and improve their overall health."

Learn more about biosimilars research

To stay informed, go to these sources and use the search function for “biosimilars” for the latest research in North America and Europe:

American College of Rheumatology

The European League Against Rheumatism

PubMed (National Center for Biotechnology Information)

Patient Views

Research and development of SEB medications is happening around the world at a rapid pace. Based on current research, what topics interest you the most?