Samsung Bioepis, the generic arm of Samsung Group, said on Nov. 9 that it has received marketing approval for its version of Roche’s blockbuster breast cancer therapy Herceptin from Korea’s Ministry of Food and Drug Safety.
Samfenet is the company’s first biosimilar for use in oncology and will help it expand its pipeline from autoimmune disease-focused therapies. Samsung Bioepis hasn’t yet decided on an exact timetable for the release and a domestic distribution partner.
Like the reference drug Herceptin, the copycat version is approved for use in several types of cancer, including metastatic breast cancer, early breast cancer and metastatic gastric cancer.
Switzerland-based Roche raked in 6.78 billion Swiss francs (US$6.78 billion) in 2016 from Herceptin, the world’s eighth top-selling drug. Herceptin posted over 100 billion won (US$89.70 million) in sales in Korea last year.
Samsung Bioepis is also aiming to bring the Herceptin biosimilar to the European market. Samfenet is now awaiting final approval from the European Commission after the European Medicines Agency said its experts backed the drug on Sept. 15.
If given the green light by November, Samsung Bioepis will have received four biosimilar approvals in the EU in less than two years, including versions of Amgen’s Enbrel, Johnson & Johnson’s Remicade and AbbVie’s Humira.
Competition to launch a Herceptin biosimilar is growing fiercer here and abroad. Samsung Bioepis’ crosstown rival Celltrion already got marketing approval for Herzuma in Korea in 2014. The drug is under review in the EU and could launch early next year.
For the US market, Samsung Bioepis hasn’t filed for approval with the US Food and Drug Administration which accepted an application for Celltrion’s Herceptin biosimilar in July.
By Park Han-na (firstname.lastname@example.org)