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Celltrion applies for approval of new Humira biosimilar to EMA
  • By Shim Hyun-tai
  • Published 2020.03.09 16:40
  • Updated 2020.03.09 16:40
  • comments 0

Celltrion said Monday that it has completed the application of its CT-P17, a new biosimilar of AbbVie’s blockbuster drug Humira (Ingredient: Adalimumab), and is waiting for approval from the Europe Medicines Agency (EMA).

Humira is a mega-selling medicine that recorded 19.2 billion won ($16 million) sales in 2019.

Celltrion submitted clinical data based on every indication approved for Humira, including rheumatoid arthritis, ulcerative colitis, and psoriasis. The company is planning to launch CT-P17 as soon as EMA approves the drug, which usually takes about a year.

CT-P17 is the first high-concentration type of medicine for a biosimilar made of adalimumab. The company has differentiated CT-P17 from existing Humira biosimilars by halving the dosage. By taking the latest trend into account, Celltrion has also removed citrate, which can cause pain in self-injection, from its latest product.

If Celltrion launches CT-P17, it will be able to complete a robust portfolio of CT-P17, Remsima IV (Intravenous), and Remsima SC (Subcutaneous) in the global autoimmune disorder treatment market. The company's biobetter, Remsima IV, has gained 59 percent of the market as of the third quarter of 2019, and Remsima SC has also been released in Germany and the United Kingdom recently.

"Our company has prepared to expand our share in the tumor necrosis factor-alpha market by acquiring sales approval for Remsima SC in November 2019 and submitting for CT-P17 license to EMA lately," a Celltrion official said. "We will do our best to obtain the go-ahead from EMA because we believe the market has high expectations of CT-P17 featuring differentiated commercial values from existing Humira biosimilars."

The biopharmaceutical company said it is also making smooth progress in clinical studies of CT-P16 and CT-P39, aiming to get at least one license of its biosimilar products every year until 2030.

shim531@docdocdoc.co.kr

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