Samsung Bioepis scores first-ever Enbrel biosim approval in EU
- Samsung Bioepis won its first major-market approval for its biosimilar version of Amgen's RA drug Enbrel, with the European Commission approving the biosim's sale in the 28 E.U. member states.
- Marketed as Benepali in Europe, the biosimilar is approved for the treatment of arthritis, psoriasis, and ankylosing spondylitis. The drug was previously approved by Korean regulators in September 2015.
- Samsung Bioepis and Biogen have an existing deal in place for Biogen to market and sell Benepali in Europe.
Amgren's Enbrel is a blockbuster rheumatoid arthritis drug which pulled in $4.7 billion worldwide in fiscal year 2014.
Samsung hopes the biologic market can be a new source of growth for the company. Samsung Biologics is positioning itself as a major contract manufacturer of biologics, while Samsung Bioepis is busily developing biosimilars. In addition to Enbrel, Samsung Bioepis has another five biosimilars in its pipeline.
While news of the approval of biosimilar Enbrel in Korea was significant as the first, this E.U. approval marks a much larger step. The EC approval is first major-market approval for a Bioepsis biosimilar candidate, and sets up possible future approval by the U.S. FDA.
- Wall Street Journal Samsung Gets European Approval for Enbrel Copy