Green Cross Neulapeg biosimilar approved in South Korea

South Korea’s Green Cross says that the country’s Ministry of Food and Drug Safety has granted marketing authorization for Neulapeg (pegteograstim), a treatment for abnormally low level of neutrophils in patient undergoing chemotherapy.

Neulapeg is a biosimilar of US biotech giant Amgen’s (Nasdaq: AMGN) Neulasta (pegfilgrastim) which together with Neupogen (filgrastim) generated sales of $1.43 billion in the second quarter of 2014. Green Cross anticipates that this approval will be an important boost to further support for the company’s efforts to expand its cancer care products.

Neulapeg is a long-acting PEGylated recombinant human granulocyte-colony stimulating factor (G-CSF), indicated for the reduction of the duration of neutropenia in patients treated to eliminate solid tumor and malignant lymphoma with cytotoxic chemotherapy. The clinical trials showed non-inferiority of the efficacy and tolerability of Neulapegto pegfilgrastim. This new medicine is intended as a fixed once-per-cycle dose, unlike currently marketed first generation G-CSF products which require four to six daily injections following each cycle of chemotherapy.