Phase III trial for subcutaneous Remsima completed

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Phase III trial for subcutaneous Remsima completed

Biosimilars/Research | Posted 19/10/2018 2 Post your comment

Celltrion Healthcare (Celltrion) announced on 29 August 2018 that it had completed a phase III study with the subcutaneous (SC) version of its infliximab biosimilar Remsima (CT‑P13).

The South Korean biotechnology company says that it is developing Remsima SC in a bid to increase its competitiveness in the TNF‑α inhibitor (autoimmune disease therapeutic agent) market through a ‘twin-track’ strategy together with the existing intravenous (IV) formulation of Remsima.

Since May 2016, Celltrion has conducted phase I and III clinical trials on the safety, pharmacokinetic and efficacy assessment of Remsima SC. The company announced in June 2018 that data had shown that the subcutaneous administration of its infliximab biosimilar (CT‑P13) was comparable in terms of efficacy and safety with IV administration of CT‑P13 (Remsima/Inflectra) up to Week 30 in patients with active Crohn’s disease (CD) [1].

As part of its ‘strategy to boost its TNF-α inhibitor market competitiveness’ the company says it is also developing its adalimumab biosimilar CT‑P17 as a ‘high-concentration formulation’.

Celltrion says that it is set to complete the clinical analysis for the subcutaneous administration of its infliximab biosimilar (CT‑P13) soon and expects to submit its application for Remsima SC to the European Medicines Agency (EMA) in the second half of 2018.

Celltrion received approval for the IV formulation of CT‑P13 as Remsima/Inflectra in Europe in September 2013 [2] and its partner Pfizer received approval for Ixifi (infliximab-qbtx) in the US in December 2017 [3]. Pfizer holds exclusive commercialisation rights of Celltrion’s Inflectra in the US.

Safety and efficacy of Remsima in IBD patients in clinical practice

Biosimilars of infliximab

References
1. GaBI Online - Generics and Biosimilars Initiative. Positive results for infliximab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 20]. Available from: www.gabionline.net/Biosimilars/Research/Positive-results-for-infliximab-and-trastuzumab-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Ixifi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 20]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Ixifi

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Source: Celltrion

Comments (2)

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Posted 25/10/2018 by Louis B, GaBI Online Editorial Office

Response to ‘Ixifi is not Celltrion's biosimilar. It's Pfizer's biosimilar.’

Thank you for your valuable comments and insight received on 22 October 2018, we have followed-up on your suggestion and researched the issue further. As a result, we have updated article ‘Phase III trial for subcutaneous Remsima completed’ with the current information.
We appreciate very much your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online. Best Regards, Louis

Posted 22/10/2018 by Tracker

Ixifi is not Celltrion's biosimilar. It's Pfizer's biosimilar.

End of this article, Ixifi is introduced as Celltrion's biosimilar. However, Ixifi is not the Celltrion's biosimilar but the Pfizer's bioismilar. Pfizer contract with Celltrion to sell Inflectra which is the infliximab biosimilar of Celltrion.