With the recent clinical trial success of the joint Merck/Samsung Bioepis Humira biosimilar, SB5, the drug development partners are setting their sights on European approval.
As AbbVie’s blockbuster Humira nears patent expiry, Merck and Samsung Bioepis seem ready to corner the market with their version of the best-selling injectable drug, which is used to treat autoimmune disorders, including rheumatoid arthritis and ankylosing spondylitis. Humira is widely regarded as the world’s best-selling medicine with sales of US$12.9 billion in 2014.
This latest success follows on from their June announcement at the European League Against Rheumatism conference of the positive Phase III results for their copies of Amgen’s Enbrel (SB4) and Johnson & Johnson’s Remicade (SB2). Together, the three reference drugs grossed more than $27 billion last year.