EMA Accepts MAA for Samsung Bioepis Biosimilar of Humira

The European Medicines Agency has accepted for review the marketing authorization application from Samsung Bioepis for its biosimilar candidate, SB5, referencing Humira (adalimumab), an anti-arthritis biologic drug. If approved, the marketing and distribution of SB5 in Europe will be handled by Biogen. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen established in 2012.

SB5 is the third anti-TNF-α biosimilar candidate that Samsung Bioepis submitted to the EMA for review following Benepali (etanercept), a biosimilar referencing Enbrel, and Flixabi (infliximab), a biosimilar referencing Remicade. Benepali received approval from the European Commission (EC) in January 2016, and Flixabi was approved by the EC in May 2016.

Humira is approved in the European Union for moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate-to-severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis. Humira is marketed by AbbVie and is the company's leading product with global net sales of $14 billion in 2015.

Samsung Bioepis is responsible for the development and manufacture of immunology and oncology biosimilar candidates in its pipeline as well as global clinical trials and regulatory registration in markets worldwide for these biosimilar candidates. Following approval, Samsung Bioepis biosimilar products are marketed and distributed by its commercialization partners, Merck & Co. and Biogen. Samsung Bioepis and Biogen have a manufacturing partnership for anti-TNF-α biosimilars. Samsung Bioepis' biosimilars are manufactured in the same drug substance facilities that have manufactured Biogen's biologic medicines.

Source: Samsung Bioepsis and Biogen

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