While providers are increasingly comfortable with switching patients with inflammatory bowel disease (IBD) from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.
While providers are increasingly comfortable with switching patients from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.
However, switching among multiple products is increasingly common in countries where tenders for medicines are undertaken regularly and in which patients may also be asked to transition among products regularly based on the outcomes of those tenders. Data arising from these biosimilar-to-biosimilar switches is beginning to emerge, however, and the results may help providers gain more comfort with switching patients among multiple biosimilars.
A study on one such switch was presented this week during the United European Gastroenterology Week 2019, being held in Barcelona, Spain.1 In the study, 133 patients with inflammatory bowel disease (IBD) who were being treated at the Southampton General Hospital in Southampton, United Kingdom, consented to be switched from one biosimilar, CT-P13 (Remsima, Inflectra), to another, SB2 (Flixabi, Renflexis).
The patients’ disease activity scores were collected at baseline and again at week 16 or week 18, depending on whether patients were receiving dosing every 6 or 8 weeks. A historical cohort of patients receiving CT-P13 was used to assess drug persistence.
The research team found that the mean modified Harvey Bradshaw Index scores and partial Mayo scores at week 0 versus week 16 or 18 were 3.13 (standard deviation [SD], 3.31) versus 3.15 (SD, 3.17) (P = .32) and 1.53 (SD, 1.75) versus 0.91 (SD, 1.64) (P = .15) respectively.
In total, 7 patients stopped treatment due to treatment failure, 6 due to AEs, and 2 due to withdrawn consent. Two patients were lost to follow-up, and 1 withdrew for other reasons. There was no significant difference in persistence, say the authors, between this cohort and the historical CT-P13 cohort.
The authors note that more long-term data are required to confirm the current findings. However, this study does add to a growing body of evidence that suggests the safety and efficacy of multiple biosimilar switching.
In fact, these results are consistent with findings concerning switching between the same 2 infliximab biosimilars in other disease states; earlier this year, during the 6th Congress of Skin Inflammation and Psoriasis International Network, researchers from Italy presented findings from a study of 24 patients with chronic plaque psoriasis who were switched from CT-P13 to SB2.2 In these patients, disease activity was substantially unchanged after the switch, and there was no statistically significant increase in AEs.
References
1. Harris C, Harris R, Young D, et al. IBD biosimilar to biosimilar infliximab switching study: preliminary results. Presented at: United European Gastroenterology Week 2019; October 29-23, 2019; Barcelona, Spain.
2. Gisondi P, Virga C, Girolomoni G. Cross-switch from CT-P13 to sb2 infliximab biosimilars in patients with chronic plaque psoriasis. Presented at: 6th Congress of Skin Inflammation and Psoriasis International Network; April 25-27, 2019; Paris, France. Abstract P049.
Spanish Real-World Study: Adalimumab Biosimilar MSB11022 Safe, Effective in IBD
May 18th 2024A real-world study in Spain on inflammatory bowel disease (IBD) patients found no meaningful changes in clinical or biochemical markers or differences in effectiveness between the adalimumab originator and the biosimilar MSB11022 (Idacio; Fresenius Kabi) in adalimumab-naïve patients.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.