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In total, 7 patients stopped treatment due to treatment failure, 6 due to AEs, and 2 due to withdrawn consent.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.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.