Blog Big Molecule Watch June 10, 2021

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.”

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