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Celltrion Announces Positive Results for Remicade Biosimilar, Remsima

Following Pfizer’s recent announcement to launch their biosimilar of Remicade (infliximab; Janssen) in November, Celltrion has now released study data that supports a safe switch to their biosimilar, Remsima (infliximab; Celltrion).

“We conducted this study to assess how switching to biosimilar infliximab affects patients who are stable on the originator biologic,” Jorgen Jahnsen, MD, professor of gastroenterology at the University of Oslo in Norway, and co-author of the NOR-SWITCH study, said in a statement.  “The data shows that safety and efficacy are maintained post-switch and should give confidence to physicians looking to move their patients onto biosimilar infliximab for non-medical reasons such as cost. I am hopeful that switching will lead to financial savings that can in turn enable more patients to receive this life-changing medicine.”

According to the results of the independent, phase IV study, Remsima kept the disease from worsening similar to participants on Remicade for at least six months before the switch. In the Remicade arm, 26.2% of participants saw their disease worsen, compared with 29.6% of Remsima participants. Due to this nonsignificant difference between the two groups, researchers concluded that the biosimilar copy was noninferior.

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Results of the study build on a growing body of real-world data that supports the safety and efficacy of Remicade. Furthermore, according to the press release, cost savings were associated with the use of Remsima across five European countries. According to the results of research from Spain, use of Remsima could allow up to 1085 extra patients per year to access therapy.

“Now more than ever, healthcare systems around the world are under pressure to reduce spending,” Man Hoon Kim, president and CEO of Celltrion Healthcare, said in a statement. “I applaud the Norwegian government for this landmark study which will enable them to reduce healthcare costs in the confidence that patients switched to biosimilar infliximab will experience efficacy and safety comparable to the originator.” —Julie Mazurkiewicz

Reference:

Celltrion Healthcare. Celltrion Healthcare: Norwegian government’s independent NOR-SWITCH study supports switching to biosimilar infliximab from originator [press release]. Business Wire. Published October 18, 2016. Accessed October 21, 2016.

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