Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

Perspective from Benjamin Click, MD. MS
Disclosures: Luber reports receiving educational grants from Ferring, Pfizer and Vifor Pharma. Please see the study for all other authors’ relevant financial disclosures.
July 16, 2021
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Switching infliximab biosimilars carries no adverse impact on IBD management

Perspective from Benjamin Click, MD. MS
Disclosures: Luber reports receiving educational grants from Ferring, Pfizer and Vifor Pharma. Please see the study for all other authors’ relevant financial disclosures.
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Patients with inflammatory bowel disease who switched from one infliximab biosimilar to another had no significant change in disease activity, according to research published in Alimentary Pharmacology and Therapeutics.

“Biological medicines account for a significant cost to health care systems in the management of IBD patients. However, since the expiration of patents for anti-tumor necrosis factor originators, biosimilars have offered the possibility of using cheaper alternatives with the potential for marked cost savings,” Raphael P. Luber, MBBS, FRACP, Guy’s and St. Thomas’ NHS Foundation Trust, and colleagues wrote. “With the licensing of more biosimilars, another conundrum has arisen, namely, the effect on disease activity and pharmacokinetics with biosimilar-to-biosimilar switching and particularly with multiple switches. Guidance with respect to interchangeability of biosimilars, encompassing both physician-directed switching and automatic substitution, differs internationally.”

In a prospective, observational cohort study, researchers evaluated 186 patients with IBD previously dosed with infliximab biosimilar CT-P13 (Remsima, Celltrion, Inflectra and Pfizer) who switched to infliximab biosimilar SB2 (Flixabi, Samsung Bioepsis). To investigate clinical outcomes, they collected C-reactive protein level, trough infliximab level and clinical disease activity indices at baseline, and early (median 16 weeks) and 1-year infusion. Additional analysis compared outcomes among patients who underwent a first therapy switch vs. a second therapy switch (n = 99).

Compared with baseline measures, researchers observed no significant change in CRP, clinical disease activity or median trough infliximab level at early infusion or 1-year among patients who underwent a first infliximab biosimilar switch (5.7 µg/mL vs. 6.6 µg/mL and 5.7 µg/mL vs. 5.7 µg/mL, respectively) or a second switch (4.3 µg/mL vs. 4.9 µg/mL and 4.3 µg/mL vs. 4.7 µg/mL, respectively). Additionally, they observed no significant change in clinical remission at early infusion (91% vs. 92%) or 1-year (91% vs. 95%).

“Switching from one infliximab biosimilar to another had no adverse impact on infliximab trough levels and disease activity. Furthermore, findings were similar among patients switching for the first or second time, supporting the possibility of multiple switches,” Luber and colleagues concluded. “There remains, however, a need to agree on the quality of evidence required to adopt this practice widely, as the performance of large-scale, randomized controlled trials of multiple switching for each individual biosimilar is probably unrealistic.”