April 25, 2024

• 

[THE INVESTOR] Korea’s biopharmaceutical firm Celltrion is pushing ahead with its clinical trial plans for a subcutaneous version of its biosimilar Remsima that will provide more convenient self-administered injection option to patients.

Celltrion is conducting clinical studies for the under the skin injection formulation of Remsima, a copycat version of Johnson & Johnson’s blockbuster arthritis treatment Remicade, in Korea and Europe, aiming to launch it in 2019 here.

“The studies are proceeding well and we hope to the new drugs globally in the first quarter of 2019,” spokesperson Lee Gun-hyuk told The Investor on June 7.

Currently, the brand-name biologic original drug and the biosimilar are only available as intramuscular injections which are administered into the muscle.

The availability of the subcutaneous formulation of Remsima would increase the treatment options available to patients, particularly those wishing to self-administer their therapy, helping them to reduce hospital visits.

According to ClinicalTrials.gov, a database of clinical studies, two separate phase 3 trials which are designed to evaluate efficacy and safety between subcutaneous and intravenous Remsima in patients with rheumatoid arthritis are underway in Korea and Europe.

The estimated completion date of the ongoing study in Korea is July 2019, with final data collection for the primary outcome scheduled for December 2018, according to the website.

“The company expects the study will meet endpoints earlier than the scheduled completion date,” Lee said.

The company also initiated phase 1 study for other indications -- Crohn’s disease and ulcerative colitis -- with 170 patients in Korea.

“The company plans to strengthen its footing in the global tumor necrosis factor alpha inhibitor market by offering the convenient SC version of Remsima as an alternative treatment for a range of immune diseases including Crohn’s disease,” he said.

Remsima took away around 37 percent of Infliximab market share in Europe as of the fourth quarter in 2016, according to IMS Health, a market data provider. The drug is available in over 80 countries including the US.

By Park Han-na (hnpark@heraldcorp.com)