European regulators back Samsung’s Remicade biosimilar

The battle for the inflammatory diseases market in Europe has begun to heat up after regulators recommended a marketing authorisation for Samsung Bioepis’ Flixabi (infliximab), the second biosimilar of J&J/MSD’s big-selling Remicade (infliximab) to receive the green light.

The positive opinion of Europe’s Committee for Medicinal Products for Human Use (CHMP) paves the way for a likely marketing authorisation from the European Commission in the coming weeks.

Samsung Bioepis said the CHMP opinion was based on phase 1 and phase 3 studies that tested the biosimilarity of Flixabi to Remicade.

The CHMP recommended Flizabi in all its EU indications – rheumatoid 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.

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.

South Korea’s Samsung says it has 13 biosimilars in it is pipeline, including near-copies of Pfizer Amgen’s Enbrel (etanercept) and AbbVie’s big-selling Humira (adalimumab). In cancer it is developing biosimilars of Roche’s Herceptin (trastuzumab) and Avastin (bevacizumab).

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