Celltrion's trastuzumab biosimilar, Herzuma, approved in South Korea

16 January 2014

South Korean biopharmaceutical firm Celltrion (Kosdaq: 068270) has received approval for its cancer treatment biosimilar monoclonal antibody (MAb) Herzuma (trastuzumab), Swiss drug major Roche’s (ROG: SIX) blockbuster cancer drug Herceptin, from Korea’s Ministry of Food and Drug Safety (MFDS).

This is the second Korean regulatory approval for a Celltrion- developed biosimilar MAb product, the first being Remsima/Inflectra (infliximab), a biosimilar of Remicade, which was also the first biosimilar MAb to be approved in Europe (The Pharma Letter September 10, 2013).

Specifically, the MFDS cleared Herzuma for the treatment of “early and advanced (metastatic) HER2-positive breast cancer as well as advanced (metastatic) stomach cancer.” Herzuma activates the body’s immune system and suppresses HER2 (human epidermal growth factor Receptor 2 protein) signals to target and destroy the tumor.

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