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The Korea Herald
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THE INVESTOR
April 23, 2024

Bio

Celltrion’s subcutaneous Remsima test results positive

  • PUBLISHED :November 01, 2017 - 16:16
  • UPDATED :November 01, 2017 - 16:16
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[THE INVESTOR] Korea’s biopharmaceutical company Celltrion unveiled new data showing that a subcutaneous version candidate of its biosimilar Remsima showed comparable efficacy and drug exposure to the existing intramuscular injection of the arthritis treatment. 





The company announced the phase 1 clinical study results of Remsima, also known as Inflectra in the US, a copycat version of Johnson & Johnson’s blockbuster treatment Remicade, at the United European Gastroenterology Week in Barcelona, Spain, on Oct. 30.

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

Results showed pharmacokinetics profiles after a single subcutaneous injection were linear by dose levels, according to the company.

“Subcutaneous administration of Remsima was found to be feasible in terms of bioavailability and safety profile and could provide patients with a more convenient and accessible treatment administration option,” a Celltrion official said. The company aims to launch the new version in 2019 here.

The result comes as Celltrion seeks to increase Remsima’s presence in the global market by introducing more convenient options and expanding indications.

At the conference, the company also showed that switching patients with Crohn’s disease from J&J’s Remicade to Celltrion’s Remsima showed comparable efficacy, safety and tolerability over a 24-week period in its new phase 3 clinical data.

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

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