Celltrion gets EU positive opinion on subcutaneous biosimilar
The company is applying to have the subcutaneous (SC) version of its biosimilar, Remsima (infliximab), approved by the European Commission (EC) and managed a step on this pathway by receiving a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP).
Remsima became the first biosimilar product to be approved by the EC in 2013.
According to the company, a SC version of the biosimilar has the potential to provide high consistency in drug exposure and a convenient method of administration. The product would also become the first SC version of the treatment, offering it a unique selling point beyond the originator product, Johnson & Johnson’s Remicade.
Global principal investigator Rene Westhovens, rheumatologist at the University Hospitals KU Leuven, explained why this delivery option may be preferable to patients, saying, “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.”
The CHMP’s decision was made based on a Phase I/III study testing individuals with rheumatoid arthritis (RA), wherein the treatment demonstrated non-inferiority to Remsima delivered intravenously.
In addition, the company is also testing the treatment for patients with inflammatory bowel disease in Phase III, to potentially expand the indication beyond RA.
Earlier this month, Celltrion signed a deal with Lonza for the latter to provide additional drug substance product to meet demand for the biosimilar in Europe and the US.
Celltrion also partnered with Chinese company, Vcell Healthcare, to see its Remsima product, as well as two other biosimilars, commercialized in the country.
