Celltrion receives CHMP positive opinion for novel subcutaneous formulation of biosimilar infliximab

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Celltrion Healthcare receives CHMP positive opinion for novel subcutaneous formulation of CT-P13 (biosimilar infliximab) for the treatment of people with rheumatoid arthritis.

Celltrion Healthcare has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for CT-P13 SC for marketing authorisation in the European Union (EU) in people with rheumatoid arthritis (RA). CT-P13 SC is the subcutaneous version of Remsima® (biosimilar infliximab, CT-P13). This recommendation will now be reviewed by the European Commission, which has the authority to approve medicines in the EU.

A subcutaneous formulation has the potential to enhance treatment options for the use of biosimilar infliximab by providing high consistency in drug exposure and a convenient method of administration.

This positive opinion is based on the phase I/III study to evaluate pharmacokinetics, efficacy and safety between CT-P13 SC and the intravenous (IV) version in people with active RA.

Part one of the study demonstrated that CT-P13 SC showed comparable efficacy to CT-P13 IV up to week 54 with comparable DAS28 (CRP) / DAS28 (ESR) and ACR20 scores (measures of disease activity) demonstrated for both routes of administration. The safety profile of CT-P13 SC was also comparable to CT-P13 IV. The study was followed up by a phase I/III randomised controlled trial (part two) which demonstrated non-inferiority in efficacy of CT-P13 SC to CT-P13 IV in people with RA over 30 weeks with similar DAS28 and ACR20, ACR50, ACR70 scores and EULAR-CRP response. The safety profile of CT-13 SC was comparable to CT-13 IV up to week 30.

A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hope to seek expanded indications following the results of this trial.

Celltrion Healthcare will adopt a different business strategy for CT-P13 SC, compared to strategies for previous products in the portfolio and is considering both direct and indirect sales based on the optimal model in each local country. Celltrion has applied for a patent for CT-P13 SC in approximately 130 countries throughout the US, Europe and Asia.