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Saturday 19 October 2019
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CHMP positive opinion for novel subcutaneous formulation of biosimilar infliximab

Celltrion Healthcare has announced that the CHMP has adopted a positive opinion for CT-P13 SC for marketing authorisation in the EU in people with rheumatoid arthritis (RA). 
 
Today’s positive CHMP opinion brings us one step closer to providing a personalised treatment approach for people living with rheumatoid arthritis. This marks an important milestone for our business providing people with a new route of administration, and a novel formulation of infliximab,” said Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “If approved, we will begin a new era in the biotherapeutic class, as CT-P13 SC would be the world’s first subcutaneous version of infliximab, expanding treatment options for physicians and their patients.”
 
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.
 
Global Principal Investigator Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium said, “This announcement is very encouraging as CT-P13 SC has demonstrated a comparable safety and efficacy profile to the well-established intravenous version of infliximab. This new SC formulation of infliximab could give patients the opportunity to administer the treatment themselves as an injection, giving them more control over their own treatment. Having two formulations of CT-P13 could also benefit patients by offering a more personalised treatment option whilst also reducing the time spent in hospital having intravenous treatment alone.”
 
A Phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hopes 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.