Celltrion receives positive opinion for Remsima® SC from CHMP
Category: #health  By Pankaj Singh  Date: 2020-06-29
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Celltrion receives positive opinion for Remsima® SC from CHMP

Celltrion Healthcare, one of the leading biopharmaceutical companies headquartered in Incheon, South Korea, has reportedly announced that CHMP (the Committee Medicinal Products for Human Use) has recommended the company to expand the marketing authorization for the subcutaneous formulation of Remsima®, for use in an additional five indications.

According to sources familiar with the knowledge of the matter, the agency has recommended expanding marketing authorization of the drug for the treatment of patients with psoriatic arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, and psoriasis. This move follows the European Union (EU) marketing authorization for Remsima® SC for the treatment of rheumatoid arthritis patients issued in Nov. 2019.

Speaking on which, Prof. Walter Reinisch, Director of the Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna said that the positive opinion of CHMP marks a pivotal step forward to meet the needs of people with autoimmune diseases.

Mr. Reinisch added that the subcutaneous formulation of Remsima® could offer patients a substitute method that offers ample exposure during maintenance treatment with infliximab and takes considerably less time than the existing intravenous formulation, thereby decreasing the time patients require to be in medical settings with infusion administrations.

During this ongoing pandemic situation, this news comes as a respite for immunocompromised patients who are required to take additional precautions and only visit clinics when necessary, states Mr. Reinisch.

Sources cite that the subcutaneous formulation of Remsima® can be administrated by patients by themselves, thereby offering alternate treatment options giving them better control and flexibility.

The positive opinion of CHMP was based on the finding from a clinical study comparing the safety, efficacy, and pharmacokinetics of the subcutaneous and intravenous formulations of Remsima® in patients with ulcerative colitis and Crohn’s disease for one year treatment period.

For the record, CHMP is EMA’s (European Medicines Agency) wing that elaborates the agency’s opinions on medical products for human use.

Source Credit - https://www.businesswire.com/news/home/20200628005037/en/Celltrion-Healthcare-Receives-Positive-CHMP-Opinion-Additional



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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