Celltrion’s CT-P13 gets CHMP positive opinion for Rheumatoid Arthritis
Category: #health  By Saipriya Iyer  Date: 2019-09-23
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Celltrion’s CT-P13 gets CHMP positive opinion for Rheumatoid Arthritis

Rheumatoid Arthritis is a progressive, long-term and a disabling autoimmune disease. Rheumatoid Arthritis affects more than 1.3 million Americans and approximately 1% of the total world’s population. Various pharmaceutical companies across the world are increasingly looking towards and finding and developing pharmaceutical solutions for this disease. 

Celltrion Healthcare, a biopharmaceutical company headquartered in Incheon, South Korea committed to offer affordable and innovative medications for advanced therapies, reportedly announced that the Committee for Medicinal Products for Human Use (CHMP), operating under the European Medicines Agency (EMA), gave a positive opinion for the company’s CT-P13 SC about marketing authorization across the European Union (EU) for people diagnosed with rheumatoid arthritis (RA).

Celltrion stated that CT-P13 SC is a subcutaneous iteration of Remsima® (infliximab biosimilar, CT-P13). Remsima SC is the first Remsima drug in the world which enables patients to inject the drug by themselves.

Now, this recommendation of CHMP would be reviewed by European Commission, which ultimately approves medicines that are sold in EU.

A subcutaneous formulation is capable of enhancing treatment options for biosimilar infliximab use by offering high consistency in exposure of drug as well as a convenient method of drug administration.

Vice Chairman at Celltrion Healthcare, Hyoung-Ki Kim stated that the positive CHMP opinion has brought the company one step closer to its aim of offering a personalized treatment method for patients having rheumatoid arthritis. This is an important milestone for the company’s business, offering people with a new administration route, as well as a novel infliximab formulation.

Kim added that If approved, the company would start a new era in biotherapeutic class, since CT-P13 SC would be the first subcutaneous infliximab version in the world, extending treatment options for patients and physicians.

The CHMP gave the positive opinion on the basis of phase I/III trial to evaluate pharmacokinetics, safety and efficacy between CT-P13 SC and intravenous (IV) version for people with active RA.

A phase III trial of CT-P13 SC for inflammatory bowel disease (IBD) patients is currently being conducted. Celltrion expects to seek extended indications following the outcomes of this phase III trial.

Celltrion first applied for industry approval of Remsima SC with CHMP back in November 2018.

 

Source credit: https://www.businesswire.com/news/home/20190922005053/en/Celltrion-Healthcare-Receives-CHMP-Positive-Opinion-Subcutaneous



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Saipriya Iyer

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Saipriya Iyer

Saipriya Iyer develops content for Market Size Forecasters, Algosonline, and myriad other platforms. A computer engineer by profession, she ventured into the field of writing for the love of playing with words. Having had a previous experience of 3 years under her bel...

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