UPDATE : Wednesday, August 5, 2020
FDA to review Samsung Bioepis’ trastuzumab biosimilar
  • By Lee Han-soo
  • Published 2017.12.20 14:37
  • Updated 2017.12.20 14:37
  • comments 0

Samsung Bioepis said Tuesday that the U.S. Food and Drug Administration (FDA) has accepted its biologics license application (BLA), and will start a review on the company’s SB3 (Original: Herceptin), a trastuzumab biosimilar.

SB3, marketed in the EU under Ontruzant, treats early breast cancer, metastatic breast cancer, and metastatic gastric cancer. Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.

The drug is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review in the U.S. Merck, also known as MSD outside of the U.S. and Canada, will market the drug if it receives approval from the FDA.

The company currently holds six biosimilar candidates that cover the therapeutic areas such as immunology, oncology, and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen.


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