Samsung Bioepis has received marketing authorization from the Korean drug regulator for its version of AbbVie’s blockbuster arthritis drug Humira to bring its third biosimilar product to the home market, according to news reports on Sept. 22.
SB5, also known as Imraldi in Europe, is a copy version of Humira, the world’s best-selling drug with US$16 billion in global sales.
Despite the green light from the Ministry of Food and Drug Safety, SB5 is unlikely to hit local pharmacy shelves soon as the patent on the original drug Hurmira expires here in January 2019.
The biosimilar was approved by the European Commission in August for treatment of rheumatoid arthritis, juvenile idiopathic arthritis and other indications.
In 2015, Samsung Bioepis received approval in Korea for Brenzys, a knockoff of Amgen’s Enbrel and Johnson & Johnson’s Remicade copycat Flexabi.
By Park Han-na (email@example.com)