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Samsung Bioepis Presents Real-World Switching Data for Renflexis


A retrospective analysis of data from the US Veterans Affairs Healthcare System database provides positive switching data for infliximab products.

Samsung Bioepis presented positive data from real-world switching and uptake studies of infliximab biosimilars in patients with inflammatory bowel disease (IBD) at the American College of Gastroenterology (ACG) 2020 Annual Scientific Meeting.

One of the studies demonstrated an 83% continuation rate among patients who were switched from reference infliximab (Remicade) to the biosimilar Renflexis. Investigators culled patient population data for the retrospective study from the US Veterans Affairs Healthcare System database.1

High Continuation Rate

The same study showed a similar continuation rate among patients who were switched from Inflectra, another biosimilar, to Renflexis, “reflecting the safety of switching from either reference product or biosimilar,” Samsung Bioepis said in a statement.

“Since IBD symptoms can be severe, maintaining a stable condition is important for IBD management. This study demonstrated that patients who were on infliximab, reference product or biosimilar, can remain stable after switching to another biosimilar, without major safety concerns,” said study leader Nabeel Khan, MD, an associate professor of clinical medicine at the University of Pennsylvania.

The second study demonstrated that adoption of Renflexis, which became the preferred infliximab product on the Veterans Affairs National Formulary (VANF) in 2018, was faster than adoption of Inflectra. The latter became listed on the VANF in 2017, suggesting that providers are becoming more comfortable with the use of infliximab biosimilar agents.2

“We are confident that this real-world switch data will provide additional reassurance to gastroenterologists who are treating patients with IBD,” said Seongwon Han, vice president and Medical & Lifecycle Safety team leader at Samsung Bioepis.

Renflexis was approved by the FDA in 2017. The goal of the first study was to augment data on the safety of switching in the real world. Patient data from January 2017 to May 2020 were included, and study requirements were that patients must have begun Renflexis prior to May 1, 2019, to provide sufficient follow-up. A minimum of 2 infusions of reference infliximab or Inflectra were required prior to initiating treatment with Renflexis, and patients must have switched to Renflexis after 3 months of stable IBD. The primary end point was Renflexis discontinuation at the 1-year point.

The investigators included 298 patients in the study and observed a 1-year Renflexis discontinuation rate of 17% (n = 52). They said 30 (10%) patients discontinued following cessation of response, which included development of resistant antibodies. Hypersensitivity led to discontinuation for 9 patients (3%).

The continuation rates for patients with a double medication switch (reference to Inflectra to Renflexis) and those with a standard single medication switch (reference to Renflexis) were similar: 82% and 87%, respectively.

The investigators noted that 13% of patients discontinued after loss of response or hypersensitivity reactions, leading them to conclude that switching from reference/Inflectra to Renflexis “through a single or double switch is relatively safe in a nationwide cohort of stable IBD patients.”

Rising Comfort Level for Infliximab Biosimilars

The second study described infliximab reference product use as the VANF policy transitioned to use of biosimilars. Again, the study looked at use of Remicade, Inflectra, and Renflexis. The originator drug was the preferred infliximab until May 2017, before it was replaced by Inflectra in that position from May 2017 to September 2018. Renflexis has held the preferred position since September 2018.

Patients with a treatment history may continue the nonformulary product under the VANF policy, but new patients must use the preferred product. These investigators studied 6 months of infliximab utilization data and found that infliximab products were used to treat 3488 veterans with IBD (60.2%, Crohn disease [CD]; 39.8%, ulcerative colitis [UC]) and the mean age was 52.5 years. Ninety percent of the patients were male.

The investigators said the mean time for the preferred formulary product to become the most commonly used product among veterans was 10 months for Inflectra and 2 months for Renflexis.

They said the percentage of patients treated with an infliximab biosimilar increased more than 800-fold (0.1% to > 86%) from the beginning to the end of the study. Prescribing patterns were similar in both UC and CD. The investigators noted no significant difference in utilization patterns for the various infliximab products, “suggesting that [Inflectra] and [Renflexis] are used in the same manner as [infliximab] originator.

They concluded that the rapid increase in use of these agents during the study period suggests that providers are becoming more comfortable with the use of biosimilar infliximab products in the treatment of IBD.


1. Pernes T, Patel M, Khan N. The safety of switching from originator infliximab or biosimilar CT-P13 to SB2 among a nationwide cohort of inflammatory bowel disease patients. Presented at: ACG 2020 Annual Scientific Meeting; October 23-28, 2020. P1597.

2. Johnson J, Sauer BC, Pinnell DK, et al. Infliximab biosimilar use for inflammatory bowel disease: a National Veterans Affairs experience. Presented at: ACG 2020 Annual Scientific Meeting; October 23-28, 2020. P1570.

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