European regulators to decide on Samsung’s Remicade biosimilar
European regulators look set to approve Samsung Bioepis’ biosimilar version of J&J/MSD’s Remicade (infliximab) this week, making it the second cut price competitor to the big-selling inflammatory diseases drug.
Samsung Bioepis confirmed that the infliximab biosimilar being discussed by the CHMP scientific committee this week is its version of Remicade.
The Korean firm filed its version of infliximab, which will be known as Flixabi, last March, in all of Remicade’s indications.
In Europe, Remicade is indicated for rheumatic arthritis, adult Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis, paediatric ulcerative colitis, psoriatic arthritis, ankylosing spondylitis and psoriasis.
There is already one biosimilar of Remicade available in Europe, which is manufactured by Celltrion and marketed by Pfizer unit Hospira and other companies.
The European Medicines Agency is set to publish the CHMP’s decision late tomorrow. If the opinion is positive, it will be passed to the European Commission for approval within the coming months.
Merck & Co, which markets Remicade in Europe under the brand name MSD, reported that sales of the drug fell to just under $1.8 billion in 2015, compared with $2.37 billion in 2014 because of the biosimilar competition.
Infliximab was the first monoclonal antibody to experience biosimilar competition and creating copies is a considerable technical achievement given the size and complexity of the originator molecule.
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