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THE INVESTOR
September 22, 2018
Big Reunion

Bio & Medicine

Celltrion to seek EU approval for Remisma SC version by year-end

  • PUBLISHED :August 29, 2018 - 14:11
  • UPDATED :August 29, 2018 - 14:13
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[THE INVESTOR] Celltrion said on Aug. 29 it has wrapped up phase 3 clinical trials for a subcutaneous formulation of its anti-inflammatory therapy Remsima, and will seek marketing approval in Europe in the second half of this year.

The biopharmaceutical firm is in the final stages of clinical data analysis for the under-the-skin version of Remsima, a biosimilar version of Johnson & Johnson’s blockbuster drug Remicade. 




It took just over two years to complete studies on Remsima SC since it started phase 1 clinical trials in May 2016.

This matches with Celltrion Chairman Seo Jung-jin’s earlier pledge to shareholders that the company will file for regulatory approval in October after completing clinical trials in September.

Once commercialized, the new injection formulation will add to the growth of existing intravenous versions of Remsima, which have already taken on the original drug in terms of market share in Europe.

The new pen-type Remsima will enable patients with mild conditions to conveniently inject the therapy by themselves without visiting hospitals.

“Celltrion expects that the potential demand base will include patients who are satisfied with the therapeutic effects of infliximab and yet who want to be administered the subcutaneous formulation,” the company said in a statement.

It also expects the new version to encompass patients with inflammatory bowel diseases who are being treated with other anti–tumor necrosis factor alpha, or TNF-α, therapies including AbbVie’s Humira, Amgen’s Enbrel, as well as the original Remicade. Patients with inflammatory bowel diseases account for some 60 percent of the TNF-α market.

Total sales of the top three blockbuster TNF-α inhibitors surpassed US$32 billion in 2016.

By Park Han-na (hnpark@heraldcorp.com

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