Uptake of rheumatology biosimilars in the absence of forced switching

ABSTRACT

Background: To describe the uptake and system-level effects of the introduction of biosimilars in a setting without forced switching.

Research design and methods: We used data from the Swedish Rheumatology Quality register from start of marketing of infliximab (Remsima® and Inflectra®) and etanercept (Benepali®) biosimilars until 31 December 2016. We compared users of each originator-product and its biosimilar(s) by line of treatment: bDMARD-naïve patients, non-medical switchers (vs. matched patients remaining on originator), and patients switching from a previous bDMARD of another type.

Results: From the start of marketing 1343 patients started an infliximab biosimilar (22 months) and 2691 started etanercept (9 months). Overall, the introduction of these biosimilars resulted in an increase of the total number of ongoing infliximab and etanercept treatments (originator + biosimilar) . At the end of the study period, biosimilars accounted for 31% of all infliximab treatments and 31% of all etanercept-treated patients. For each line of therapy, we noted only small differences in patient characteristics between those starting the originator product vs. its biosimilar(s).

Conclusions: Introduction of biosimilars have effects beyond replacement of the originator product, in terms of an increased rate of bDMARD initiation. Selection to non-medical switching displayed no particular disease- or patient-characteristics.

KEYWORDS:

• bDMARD
• biosimilar
• rheumatology
• uptake

Author contributions

All authors participated in the study design and in writing the manuscript, interpreted the data and critically reviewed the paper, and read and approved the final manuscript. D Di Giuseppe and J Askling performed the data collection. D Di Giuseppe analysed the data and wrote the manuscript.

Declaration of interest

The ARTIS Study Group conducts scientific analyses using data from the Swedish Biologics Register ARTIS, run by the Swedish Society for Rheumatology. ARTIS has entered into agreements with Abbvie, BMS, MSD, Lilly, Pfizer, Roche, Samsung Bioepis, and UCB. H Forsblad-d’Elia has received advisory board fees from Sandoz, Novartis and Abbvie and an unrestricted research grant from Novartis. J Askling has received grant support from Abbvie, MSD, Lilly, Pfizer, Roche, Samsung Bioepis, and UCB, mainly in relation to safety monitoring of biologics using the ARTIS register. This study was approved by the Regional Research Ethics Board at the Karolinska Institute. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. A peer review on this manuscript has disclosed that he is a consultant of Pfizer, Sandoz, Abbvie and Janssen and coordinates the Latin American forum on biosimilars.

Additional information

Funding

This study was supported by the Swedish Foundation for Strategic Research, Swedish Research Council, Swedish Cancer Society, Swedish Heart Lung Foundation, ALF funding collaboration between Karolinska Institute and Stockholm County, Forskningsrådet om Hälsa, Arbetsliv och Välfärd 2015-00689, Stiftelsen för Strategisk Forskning and Cancerfonden. D Di Giuseppe was supported with a PostDoc grant by the Swedish Research Council for Health, Working Life and Welfare [grant number 2015-00689].