Study data supports switch to Celltrion’s Remicade biosimilar
pharmafile | March 18, 2016 | News story | Research and Development |
Celltrion and distribution partner Mundipharma have presented study data supporting switching irritable bowel disease (IBD) patients from Remicade to biosimilar infliximab.
Data was shown today at the 11th Congress of European Crohn’s and Colitis Organisation (ECCO) from ten studies of 589 patients, including 325 patients with Crohn’s disease (CD), 128 patients with ulcerative colitis (UC) and 136 patients where the type of IBD was not specified.
One study which included 74 IBD patients found comparable efficacy and safety after switching patients from the reference infliximab (manufactured by Janssen) to Celltrion’s biosimilar version, which was recently recommended for approval by an FDA advisory committee.
Janssen, for its part, argued at the time that Celltrion had not provided sufficient data comparing its biosimilar to Remicade in treating IBS conditions to support its approval in Chron’s disease and ulcerative colitis indications, but this new data could go some way to righting that.
The largest single cohort of patient switch data presented at ECCO was from a study by Southampton General Hospital in the UK, which included 134 IBD patients. The service outcome evaluation found no significant change in drug persistence between patients treated with the biosimilar and those treated with the reference product.
Biosimilars, highly similar versions of biologic drugs, are seen as offering a more affordable version of such drugs that could potentially save healthcare systems considerable sums of money. Typical discounts offered by biosimilar drugs to their branded counterparts are in the region of 20-30%.
Further data from a survey conducted by ECCO were also presented, which demonstrate the growing approval for biosimilar adoption among IBD specialists since 2013, when research was last undertaken by the organisation.
The survey of 118 IBD healthcare professionals found that 92.4% regarded potential cost savings as the main advantage of biosimilars. The survey also found that only a quarter (25%) of those asked would not extrapolate data across IBD classifications, and that 44% considered biosimilars to be interchangeable with their reference products.
However, almost one in five (19.5%) said they felt little or no confidence in the use of biosimilars, suggesting there is still work to be done by manufacturers to promote and prove their safety and efficacy. 75% of respondents felt that medical societies should promote information on biosimilars.
Lead researcher Professor Silvio Danese, Humanitas Clinical and Research Center, Italy, comments: “This research demonstrates that IBD specialists are generally informed and well educated about biosimilars and it’s evident that physician confidence in biosimilars has grown since 2013. There are fewer concerns and increased confidence about the use of biosimilars in clinical practice.”
Joel Levy
