Will US Follow UK on Managed Biosimilar Switching of IBD Patients on Infliximab?

Jackie Syrop

A study of a managed switching program among patients with inflammatory bowel disease (IBD), who were treated with infliximab (Remicade) and then switched to its biosimilar CT-P13 infliximab (Inflectra/Remsima), found that switching delivered significant cost savings and resulted in no significant differences between the 2 medications in terms of drug persistence, side effects, adverse reactions, disease activity, or biochemical response. The study has been published in the Journal of Crohn’s and Colitis.1

The study followed 143 patients with IBD (118, Crohn’s disease; 23, ulcerative colitis; and 2, unclassified IBD), all of whom had been on reference infliximab and agreed to participate in the switching program. Evaluation outcomes included drug persistence, changes in drug acquisition costs, patient-reported side effects, adverse events, patient outcomes assessed using the IBD-control Patient-Reported Outcome Measures questionnaire (IBD-Control-8), serum drug and antibody levels, and routinely collected biochemical markers. Patients reported a similar incidence of side effects before and after the switch. No clinically significant differences were observed in mean C-reaction protein, albumin, hemoglobin levels, or platelet and white cell counts after the switch to CT-P13. The mean IBD-control-8 score improved from 10.4 to 11.2 (P = .041). There was no significant difference in drug persistence between biosimilar and reference infliximab (P = .94) and no increase in immunogenic response to the biosimilar.

Investment in the new program, including salary for an IBD specialist nurse and other support staff, was about 12% of expected cost savings. The analysis showed substantial cost savings to the health economy, part of which has been reinvested in not only delivering the program but also improving the service and quality of care for the whole IBD patient population in Southampton—not just for biologics-treated patients. The authors write that drug acquisition costs fell by £40,000 to £60,000 pounds (approximately $50,000 to $75,000) after the managed switching program began.

In the European Union (EU), interchangeability of approved biosimilars with reference biologics does not require prescriber approval. However, in the United States, pharmacy-level switching is not allowed unless a biosimilar has the FDA’s interchangeable designation; none of the US-approved biosimilars are yet deemed interchangeable. Switching studies such as this are likely to play an important role in demonstrating the interchangeability of US biosimilars and reference drugs, according to the recently issued FDA draft guidance for pharma.

Some US experts consider biosimilar interchangeability critical to the successful market uptake of biosimilars and key to bringing down prices of biosimilars to significantly lower levels than reference drugs. However, other analysts suggest that interchangeability may become less important for commercial competitiveness because some 2017 formularies are already choosing biosimilars instead of reference brands.2,3

Surveys of US pharmacists found that nearly three-quarters said they would feel comfortable or very confident substituting an interchangeable biosimilar for its branded biologic counterpart if the 2 products share the same nonproprietary name, had precise product identification, and complete and transparent labeling to ease follow-up on patient outcomes and safety.4,5

Physicians, however, have expressed concerns about switching patients from reference biologics to biosimilars because biosimilars, unlike generics of non-biologic drugs, cannot be exact copies of biologics because of the complex nature of biological drug proteins.6 Surveys suggest the majority of physicians in the EU (63%) are open to the idea of biosimilar substitution.7 US physicians and patients appear to have a little farther to go in acceptance of biosimilars in place of reference medications.

A 2015 survey of US physicians showed less (48%) support for biosimilar substitution; physicians say they are concerned patients could develop immunogenic reactions to biosimilars, forever threatening treatment response to the drug.6 Patients who are satisfied with their therapeutic response to the reference biologic may resist switching to biosimilars because of the unknown experience with a biosimilar.6

Education is key to building up acceptance of biosimilars among patients and physicians because patients are open to shared decision-making with physicians—if physicians are open to using biosimilars, patients tend to trust their judgment.7

References

  1. Razanskaite V, Bettey M, Downey L, et al. Biosimilar infliximab in inflammatory bowel disease: outcomes of a managed switching programme [published online January 27, 2017]. J Crohns Colitis. doi: 10.1093/ecco-jcc/jjw216.
  2. Felix AE, Gupta A, Cohen J, Riggs K. Barriers to market uptake of biosimilars in the US. GaBI Journal. 2014;3:108-115.
  3. Slone WL, Murphy MF. “Stop the presses”: biosimilar development & interchangeability. Worldwide Clinical Trials website. Worldwide Clinical Trials website. www.worldwide.com/blog/2017/02/stop-presses-biosimilar-development-interchangeability/?utm_source=6326&utm_medium=Twitter&utm_campaign=voicestorm. Accessed February 21, 2017.
  4. Survey: Pharmacists are most confident substituting interchangeable biosimilars for brand biologics when products share nonproprietary name. Pharmacy Times website. http://www.pharmacytimes.com/association-news/survey-pharmacists-are-most-confident-substituting-interchangeable-biosimilars-for-brand-biologics-when-products-share-nonproprietary-name. Published February 27, 2015. Accessed February 21, 2017.
  5. ASBM releases pharmacist survey: findings show strong support for distinguishable names for biologics and need for transparency in labeling. Biosimilar Development website. www.biosimilardevelopment.com/doc/asbm-pharmacist-distinguishable-biologics-transparency-in-labeling-0001. Published October 13, 2015. Accessed February 21, 2017.
  6. McDonald C. Biosimilars in the US: five potential sticking points. Pharmaceutical Executive website. www.pharmexec.com/biosimilars-us-five-potential-sticking-points. Published April 21, 2015Accessed February 21, 2017.
  7. Metcalf M. Biosimilars: bringing patients into the conversation. eyeforpharma website. http://social.eyeforpharma.com/column/biosimilars-bringing-patients-conversation. Published January 20, 2017. Accessed February 17, 2017.