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NOR-SWITCH Results ‘Concerning’ In Crohn’s Disease, Says Janssen

Executive Summary

Janssen Biotech says that the NOR-SWITCH study on switching from Remicade to biosimilar infliximab raises “significant questions” over safety and efficacy in patients with Crohn’s disease, and does not support interchangeability.

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‘Non-Medical Switching’ Claim Riles Europe’s Biosimilars Industry

Two patient advocacy groups have said that a number of issues surrounding biosimilar switching, patient consent and traceability remain to be addressed in Europe, despite growing support for biosimilar use from physician bodies and clinical studies. But the European biosimilars industry has dismissed these concerns, saying that biosimilar medicines will significantly improve access to biologics patients while contributing to the sustainability of pharmaceutical budgets.

‘Non-Medical Switching’ Claim Riles Europe’s Biosimilars Industry

Two patient advocacy groups have said that a number of issues surrounding biosimilar switching, patient consent and traceability remain to be addressed in Europe, despite growing support for biosimilar use from physician bodies and clinical studies. But the European biosimilars industry has dismissed these concerns, saying that biosimilar medicines will significantly improve access to biologics patients while contributing to the sustainability of pharmaceutical budgets.

ACR 2016 Roundup: Remicade Copy Not So Similar; Mixed Sirukumab Results; Corbus’s Resunab Surge

At ACR: Janssen reported data that show Celltrion’s Remicade biosimilar is not quite the same, but positive sirukumab results may not boost the Janssen and GSK biologic’s market prospects. Meanwhile, Corbus surged on mid-stage resunab results in systemic sclerosis, Janssen shared Phase II gesulkumab psoriasis results, Genentech eyes a new Actemra indication, and Xencor rose on interim Phase II data.

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