Positive Results From Ustekinumab Biosimilar Phase I Trial and Infliximab Biosimilar Switching Studies



On October 20, 2020, NeuClone announced that it successfully completed its Phase I clinical trial of NeuLara, its proposed biosimilar of Stelara (ustekinumab).  According to Neuclone, the Phase I clinical trial demonstrated similar clinical pharmacokinetics, and safety, immunogenicity and tolerability profiles of NeuLara compared to US- and EU-sourced Stelara.  NeuLara is NeuClone’s second biosimilar to have met all primary and secondary endpoints in a three-arm Phase I trial.  As we previously reported on December 18, 2019, the biosimilar candidate is one of several that NeuClone is developing in partnership with the Serum Institute of India.  According to Noelle Sunstrom, CEO of NeuClone, NeuLara is “on track for a global Phase III trial starting in 2021 and to be among the first biosimilar entrants, making [NeuLara] available to many more patients with psoriasis and inflammatory bowel diseases.”

At the American College of Gastroenterology (ACG) 2020 Annual Scientific Meeting being held from October 23-28, 2020, Samsung Bioepis presented switching data for its infliximab biosimilar, Renflexis, with the reference product, Remicade, in patients with IBD.  According to Samsung Bioepis, the study1 demonstrated an 83% continuation rate among patients who were switched from Remicade to Renflexis, and a similar continuation rate among patients who were switched to Renflexis from another biosimilar, Inflectra.  The company stated that the study results “reflect[] the safety of switching from either reference product or biosimilar”.  Samsung Bioepis further reported that a second study2 showed that adoption of Renflexis was faster than the adoption of Inflectra, which according to the company, suggested that providers are becoming more comfortable with the use of infliximab biosimilar agents.  Seongwon Han, Vice President and Medical & Lifecycle Safety team leader at Samsung Bioepis, stated that “[w]e are confident that this real-world switch data will provide additional reassurance to gastroenterologists who are treating patients with IBD [Inflammatory Bowel Disease]”.

1Pernes 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.

2Johnson 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

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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