Wednesday, 22 Jan 2020

You are here

Nor-Switch Study Shows it's Safe to Switch to a Biosimilar

The results of the Nor-Switch study were presented at the United European Gastroenterology annual congress this week demonstrating no significant difference in effect, adverse effects or antibody formation in patients switched from Remicade to the biosimilar infliximab (CT-P13, Remsima). Outcomes were compared to those who continued to take IV Remicade.

Dr. Tore Kvien presented the results stating that "the results are not suprising".

The primary endpoint of the study was disease worsening, which occurred in 26,2% of those continuing infliximab versus 29,6% in those switched to CT-P13.

The Nor-Switch study, sponsored by the Norwegian government, involved nearly 500 patients at 40 sites across Norway who had been on stable infliximab treatment for at least six months given to treat chronic inflammatory diseases Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis. 

Nearly half of the patients were switched to Celltrions CT-P13 (Remsima) with similar remission rates and safety findings. 

While the introduction of biosimilars will result in cost savings, the hope is that this will lead to increased access for patients.  In Norway the cost of biosimilar infliximab (Remsima or Inflectra) was substantially lower (70% discount) than the just announced 15% discount being offered in the USA for the same product CT-P13 (Inflectra).

However, when real-world savings were analyzed in five European countries: Germany, France, Italy, Spain and UK, the use of biosimilar infliximab (CT-P13), resulted in a 2015 total cost savings ranging from €1.35 million in Germany to €5.97 million in Spain. There were no cost savings in France, as the price of biosimilar infliximab (CT-P13) and originator were the same.

 

Disclosures: 
The author has received compensation as an advisor or consultant on this subject

Add new comment

More Like This

Best of 2019 - The Shame Behind Adalimumab Biosimilars

JAMA has an article this week on the shift from biologic drugs to less expensive therapeutic biosimilar agents. The impact of biosimilars can be easily represented by the shift from adalimuamb - a biologic with nearly $19 billion in sales in 2018 - to any one of the four FDA approved biosimilars for adalimumab (see the daily download for slides on new adalimumab and other biosimilars).

Psoriasis Risk Increased with TNF Inhibitors in Juveniles

Children with inflammatory diseases who were treated with tumor necrosis factor (TNF) inhibitors had a higher rate of incident psoriasis than those not exposed to these biologics, a single-center retrospective study found.

The Shame Behind Adalimumab Biosimilars

JAMA has an article this week on the shift from biologic drugs to less expensive therapeutic biosimilar agents. The impact of biosimilars can be easily represented by the shift from adalimuamb - a biologic with nearly $19 billion in sales in 2018 - to any one of the four FDA approved biosimilars for adalimumab (see the daily download for slides on new adalimumab and other biosimilars).

Pain Persists Despite TNF Inhibitor Use

Control of pain in patients with rheumatoid arthritis (RA) often focuses on control of inflammation as a means to better control pain. However, a new claims data study shows that while anti-tumor necrosis factor inhibitor (TNFi) may lower the use of opioids, the reduction is nominal, suggesting that a substantial amount of pain is not adequately addressed by TNFi - a potent anti-inflammatory approach.

Adalimumab and Pregnancy Outcomes

A prospective study of birth outcomes to mothers exposed to adalimumab (ADA) between 2004 and 2016 was conducted by Organization of Teratology Information Specialists (OTIS) Research Center at the University of California San Diego, and showed that ADA exposure was not associated with an increased risk for any of the adverse outcomes examined.