Celltrion applies for Korean approval of biosimilar trastuzumab

Biosimilars/News | Posted 07/06/2013 post-comment0 Post your comment

On 4 June 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of its biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Trastuzumab Herceptin V13D12

CT-P6 is intended to be a biosimilar of Roche’s breast cancer blockbuster Herceptin (trastuzumab). Herceptin is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer.

A phase I/IIb double-blind, randomized study of CT-P6 carried out in South Korea demonstrated an equivalent pharmacokinetic profile for CT-P6 compared to trastuzumab. The company is also carrying out a phase III trial in Romania with CT-P6 to compare the biosimilar candidate to trastuzumab with the aim of demonstrating comparable efficacy and safety [1].

Roche’s Herceptin has generated sales over US$6.3 billion globally in 2012. CT-P6 is the first trastuzumab biosimilar to enter the regulatory approval procedure.

Celltrion has already had its first monoclonal antibody, Remsima (infliximab), approved by the Korean Food and Drug Administration and has applied to EMA for approval of the drug [2, 3]. Remsima has also, according to Celltrion, been approved by various other countries and sales of Remsima have commenced in these foreign markets.

Celltrion has an agreement to develop and market eight biosimilars, including infliximab, with US-based generics major Hospira. The company has at least six other biosimilars in various stages of development, covering indications such as breast cancer, non-Hodgkin’s lymphoma, colorectal cancer, colon cancer and respiratory syncytial virus. The company did, however, recently stop a phase III trial of its biosimilar rituximab candidate (CT-P10) in order to first complete phase I trials with the biosimilar [4].

Editor’s comment
It should be noted that biosimilars approved outside of the EU might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. EMA regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related article

Biosimilars applications under review by EMA – 2013 Q1


1.  GaBI Online - Generics and Biosimilars Initiative. Phase I/IIb trial of CT-P6 shows comparability to trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Biosimilars/Research/Phase-I-IIb-trial-of-CT-P6-shows-comparability-to-trastuzumab

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

3.  GaBI Online - Generics and Biosimilars Initiative. EMA reviews its first biosimilar monoclonal antibody [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/EMA-reviews-its-first-biosimilar-monoclonal-antibody

4.  GaBI Online - Generics and Biosimilars Initiative. Celltrion stops phase III trial of biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 7]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-stops-phase-III-trial-of-biosimilar-rituximab

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Source: Celltrion

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