EMA to Review Celltrion's Subcutaneous Infliximab Biosimilar

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra). The company says that it expects the EMA’s Committee for Medicinal Products for Human Use to deliver an opinion on the proposed formulation in the second half of 2019.

Celltrion is unique among biosimilar developers in that it has been pursuing a strategy to develop biosimilars of existing formulations of intravenously delivered biologics while simultaneously developing easier-to-use, patient-administered subcutaneous versions of the same biosimilars. These formulations, it says, will largely serve patients who are currently being successfully treated with originator biologics but who would benefit from being able to self-administer their therapies instead of traveling to infusion centers for administration.

In September of this year, Celltrion announced that it had completed its phase 3 clinical trial of the subcutaneous formulation. During the 2018 European League Against Rheumatism's Annual European Congress of Rheumatology, researchers reported that the subcutaneous formulation had similar efficacy and generally similar safety to the currently approved intravenous product in patients with rheumatoid arthritis.

Separately, Celltrion revealed positive results from a phase 1 study comparing the subcutaneous formulation to the approved formulation in patients with Crohn disease, and the study’s authors wrote that pharmacokinetic and pharmacodynamic modeling based on the comparable efficacy and safety results in the study suggest that the subcutaneous and intravenous doses of CT-P13 are similar.

If the company is successful in securing a marketing authorization for this formulation of its product, Celltrion will the sole developer to market a subcutaneous infliximab option.

Meanwhile, reference product sponsors have been pursuing approval for subcutaneous formulations of their own drugs in a bid to secure their market share for a variety of therapeutic areas. Roche, together with Halozyme, has successfully developed a subcutaneous version of its reference trastuzumab, Herceptin.

Roche has also developed a subcutaneous formulation of its brand-name rituximab, Rituxan, though the subcutaneous version of the drug that treats a variety of malignant and nonmalignant conditions is only approved in the United States, European Union, and other regulatory territories for the treatment of leukemia and lymphoma.