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December 17, 2018

Celltrion seeks EU approval for Remsima SC

PUBLISHED : December 03, 2018 - 15:47

UPDATED : December 03, 2018 - 15:48

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[THE INVESTOR] Celltrion said on Dec. 2 that the European Medicines Agency has accepted its application for marketing authorization to a subcutaneous version of Remsima, its biosimilar of autoimmune disease therapy Johnson & Johnson’s Remicade.

An opinion from the European health regulator’s Committee for Medicinal Products for Human Use is expected in the second half of 2019.




The under-the-skin injection formula is designed to offer a more convenient self-administered pen type option to patients and secure competitiveness in the market of anti–tumor necrosis factor alpha, or TNF-α, therapies through a “twin-track” strategy together with the existing intravenous formulation of Remsima, the company said.

The IV formulation version was launched in Europe in 2015.

“Celltrion is set to promote its Remsima and Remsima SC as global blockbusters by increasing the brand share in TNF-α inhibitor market under the strategy of diversifying products with existing IV formulation of Remsima, already sharing 52 percent of the Europe’s original medicine market,” a Celltiron official said.

If Remsima SC becomes available, Celltrion will be able to enter the market of other TNF-α inhibitor therapies including Humira, Enbrel and Enbrel biosimilars. The combined market size of the therapies stands at around US$7.84 billion, according to KB Securities analyst Lee Tae-young.

“In addition to these efforts, we will lead the TNF-α inhibitor market with the upcoming commercialization of the SC formulation of ‘CT-P17’ as a high-concentration formulation of a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is undergoing clinical trials,” the official said.

By Park Han-na (hnpark@heraldcorp.com

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