Friday, 18 Oct 2019

You are here

Biosimilar Switching Shows Favorable Interchangeability

Interchangeability is a major issue that will determine the success of biosimilars. While the FDA has a guidance document on biosimilar development, it has not clearly defined guidance on the issue of interchangeability - defined as the ability of the biosimilar to produce “the same clinical results as the reference product in any given patient and that switching between the two is safe.”  Hence, changing from Remicade to its new biosimilar will need to be equally effective and safe, impose new issues or immunogenicity concerns before such a practice can be put into place. 

With the recent approval of Inflectra, there was limited data presented at the FDA hearing about interchangeability.  This data has just been published in Annals of Rheumatic Disease, wherein the open-label extension portion of the PLANETAS study tested the interchangeability of CT-P13 (infliximab biosimilar) and Remicade in ankylosing spondylitis patients. 

Some patients treated with CT-P13 in the main PLANETAS study remained on the biosimilar in the extension study (maintenance group) and others were switched from Remicade to CT-P13 during the extension study (switch group).

Overall, 174 AS patients were enrolled in the extension and randomized to maintenance or switch groups. CT-P13 (5 mg/kg) was administered intravenously every 8 weeks for another year.

ASAS20 response rates at week 102 were 80.7% and 76.9% for the maintenance and switch groups, respectively. ASAS40 and ASAS partial remission were also similar between groups. Anti-drug antibody positivity rates were comparable (week 102: 23.3% vs 27.4%). Adverse events led to treatment discontinuation during the extension study in 3 (3.3%) and 4 (4.8%) patients, respectively.

This is the first study to show that switching from the reference product (Remicade) to its biosimilar CT-P13 is possible without negative effects on safety or efficacy in patients with AS.

 

Add new comment

More Like This

Enbrel Patent Battle Won by Amgen

The ugly, legal, financial underbelly of US biosimilar drug development showed up in court last Friday, when a U.S. judge upheld two of Amgen's patents for Enbrel, thwarting a legal challenge by Novartis/Sandoz over its etanercept-szzs biosimilar, Erelzi. 

Sandoz won FDA approval for their etanercept biosimilar in 2016, but has not been able to market Erelzi because of Amgen’s extended patent protection (till 2029).

TNF Inhibitor and Biologic Induced Psoriasis

Analysis of RA patients in the German biologics register, RABBIT, shows an increased risk of psoriasis with TNF inhibitor (TNFi) compared to csDMARDs and other non-TNFi biologics. 

Among RABBIT RA patients without (n = 14,525) or with a history of psoriasis (n = 375) they assessed the risk of incident psoriasis or flare according to what biologic or csDMARD taken.

FDA Approves Cimzia for Non-Radiographic Axial Spondyloarthritis

The U.S. Food and Drug Administration today approved Cimzia (certolizumab pegol) injection for treatment of adults with a certain type of inflammatory arthritis called non-radiographic axial spondyloarthritis (nr-axSpA), with objective signs of inflammation. This is the first time that the FDA has approved a treatment for nr-axSpA.

Lower TNF Inhibitor Persistence in Spondylitis

A claims data analysis shows that only one-third of ankylosing spondylitis (AS) treated with tumor necrosis factor inhibitors (TNFi) therapy remain on their initial drug in the 2 years post initiation.

The Risk of Tuberculosis with TNF Inhibitors

A study from Turkey shows that among 2117 patients treated with a TNF inhibitor (TNFi) the risk of developing TB was 6 fold higher in those treated with a TNFi compared to non-users.

This retrospective cohort study included patients with rheumatoid arthritis (RA), ankylosing spondylitis, juvenile idiopathic arthritis or psoriatic arthritis (PsA) that treated with or without TNFI. The calculated the 2-year RR of TB after TNFi.