Celltrion Amps Up Its Biosimilar Launch Schedule

Incheon, Korea-based Celltrion Healthcare has announced plans to step more broadly into the global biosimilars space with what it calls a “game changing” strategy to launch up to 10 new biosimilars over the coming decade, coupled with development of an aggressive European sales network.

In a release, Celltrion Chairman Jung Jin Seo said the company will build on its existing portfolio of treatments that include Remsima SC, a subcutaneous formulation of infliximab for the treatment of rheumatoid arthritis (RA) and Crohn disease, among others. Remsima SC was approved by the European Commission for patients with RA in November 2019. The company seeks a further indication for inflammatory bowel disease and hopes for a mid-2020 decision.

With the infliximab biosimilar, Celltrion hopes to take command of the global tumor necrosis factor-α inhibitors market, which the company estimates will reach “approximately $50 billion."

Celltrion also produces the rituximab biosimilar Truxima and the trastuzumab biosimilar Herzuma, as well as other forms of infliximab. In April 2016, the FDA approved the injectable biosimilar infliximab-dyyb under the trade name Inflectra. In the United States, Remsima SC is expected to receive FDA approval by 2022, the company said.

‘‘Celltrion boasts a strong and dynamic product portfolio and pipeline,” Seo said. “Biosimilars and value-added medicines, which we call ‘bioinnovatives’ (innovative biosimilars) are set to be our key growth drivers in 2020.” If the company manages to execute on its ambitious biosimilars schedule, Celltrion would have 18 biosimilars on market by 2030.

The announcement at the JP Morgan Healthcare Conference in San Francisco last week was followed by Celltrion’s announcement this week that it plans to open a large biologics manufacturing plant in Wuhan, China.

The company has scheduled an April groundbreaking for the 5-year construction of the $514 million plant. The facility will manufacture biologics for the Chinese market and do contract manufacturing for other pharmaceutical companies.

The market is ripe for the launch of biosimilars, Seo continued. Healthcare budgets are under pressure, there’s a demand for lower-cost medicines, and biologic agent prescriptions are on the rise, he said. These factors have already been octane for biosimilar industry growth.

A recent market report from healthcare consulting firm IQVIA indicated that Remsima SC has taken a 59% share of the market from the reference product, Janssen’s Remicade. Similarly, Truxima and Herzuma have achieved market shares of 38% and 15%, respectively, based on the report.

“These figures place Truxima and Herzuma as the leading biosimilars in terms of market share within the rituximab and trastuzumab markets,” Celltrion said.

Ho Ung Kim, head of the medical and marketing division at Celltrion, said the investment in biosimilars includes the development of a sales network in 14 European companies.

Seo also outlined a new drug development plan, which is designed to increase the delivery efficiency of antibody-drug conjugates and their cell penetration, which he said can potentially improve cancer treatments.