Celltrion’s subcutaneous infliximab biosimilar secures CHMP recommendation

pharmafile | September 24, 2019 | News story | Manufacturing and Production, Sales and Marketing EMA, EU, Europe, biosimilar, celltrion, infliximab, pharma 

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has given its recommendation to Celltrion’s CT-P13 SC, the subcutaneous version of Remsima (biosimilar infliximab), in the treatment of rheumatoid arthritis, it has emerged.

As a subcutaneous formulation, the therapy “has the potential to enhance treatment options…by providing high consistency in drug exposure and a convenient method of administration,” according to the manufacturer.

The recommendation was based on Phase 1 and 3 data which showed that Celltrion’s biosimilar demonstrated comparable efficacy to its originator product up to 54 weeks of treatment, while it was also found to be comparable up to week 30.

“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,” explained Global Principal Investigator Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven in Belgium. “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.”

Vice Chairman at Celltrion’s Vice Chairman Hyoung-Ki Kim remarked: “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. 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.”

The European Commission is now due to review this recommendation; there is no obligation for the Commission to act on the CHMP’s advice, but historically it tends to follow the committee’s advice.

Matt Fellows

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