Celltrion Says Its Biosimilar Has Gained 56% of the European Infliximab Market

Biosimilar developer Celltrion has seen strong success with its biosimilar infliximab, CT-P13, which is marketed in the United States as Inflectra and in other territories as Remsima. This week, the company said that its product has captured 56% of the infliximab market in Europe as of the third quarter of 2018.

That number was reported by Celltrion’s chairman, Jung-Jin Seo, during his presentation at the 37th Annual J.P. Morgan Healthcare Conference held January 7-10 in San Francisco, California. Looking to the future, Hyoung-Ki Kim, Celltrion’s vice chairman, added in a statement that the development of the as-yet unapproved subcutaneously administered version of the product, which has the potential to give patients an alternative to regular infusions and reduce infusion-related costs, will be a key focus of the company in 2019.

According to Celltrion, a launch of the subcutaneous CT-P13 product could bring the total value of the biosimilar infliximab market from $9.2 billion in 2019 to $42.8 billion in 2020.

The European Medicines Agency is currently reviewing the proposed formulation, having accepted an extension marketing authorization application for review in December 2018. Celltrion’s data package for the formulation includes results from a phase 3 clinical trial, results of which were reported at the 2018 European League Against Rheumatism's Annual European Congress of Rheumatology. The study’s investigators 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's disease, and the researchers found 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 Celltrion is successful in securing a marketing authorization for this formulation of its product, the company will the sole developer—whether innovator or biosimilar—to market a subcutaneous infliximab option.

Celltrion also highlighted its success with CT-P10, its rituximab biosimilar authorized in the US and EU markets as Truxima. While the biosimilar has not yet launched in the United States, it has, said Celltrion, captured 35% of the share for the rituximab market in 16 European countries as of the third quarter of 2018. In the so-called “EU 5”—the United Kingdom, Germany, France, Italy, and Spain—the biosimilar has reached 36% market share.