Celltrion Shares Recent Biosimilar Development News

Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA).  According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients receiving maintenance therapy and in patients switched from reference adalimumab to CT-P17 up to week 52.”

In the same press release, Celltrion also announced that the European Commission has granted marketing authorization for Celltrion’s subcutaneous infliximab biosimilar, Remsima™ SC (CT-P13 SC), for new and existing RA patients.  Celltrion Healthcare Canada Limited announced this week that it has launched Remsima™ SC in Canada for the treatment of adult patients with RA.  Jovan Antunovic, Commercial Director at Celltrion Healthcare Canada, noted that Celltrion is  “delighted to be able to launch Remsima™ SC …and to bring the first and only subcutaneous form of infliximab to patients, payers and clinicians in Canada.”

Celltrion also announced this week that it has acquired a controlling stake of Iksuda Therapeutics, a British antibody-drug conjugate (ADC) developer.  Celltrion said it “was looking for a business model that could generate revenue and value from products other than biosimilars and chemical drugs,” and, “[a]gainst this backdrop, we decided to invest in Iksuda, which specializes in ADC, as it can create synergy with Celltrion’s antibody treatments.”