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Pegteograstim biological approved in South Korea Posted 19/09/2014

South Korean biologicals company, Green Cross, announced on 18 August 2014 that it had received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for its pegteograstim biological Neurapeg.

Pegteograstim is a is a new formulation of PEGylated recombinant human granulocyte colony-stimulating factor (G-CSF) analogue pegfilgrastim. It stimulates the level of white blood cells (neutrophils) [1]. Neurapeg will be used as a treatment for neutropenia (abnormally low level of neutrophils) in patients undergoing chemotherapy.

The South Korean approval is based on clinical trials, which showed the non-inferiority Neurapeg to Amgen’s originator product Neulasta (pegfilgrastim) in terms of efficacy and tolerability. Neurapeg is intended as a fixed once-per-cycle dose, unlike currently marketed first generation G-CSF products, which require 4 to 6 daily injections following each cycle of chemotherapy.

The approval is a ‘significant milestone’ for Green Cross, being the company’s first cancer treatment drug. Neurapeg will be available in the Korean market in early 2015 and the company is also ‘poised to accelerate the introduction of Neurapeg into foreign markets’, according to Green Cross Oncology Team Leader Mr Su-Jung Kim.

Related article
South Korean guidelines for biosimilars

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. Sandoz advances biosimilars pipeline [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 19]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-advances-biosimilars-pipeline

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Source: Green Cross, MFDS

Comments (2)

Response to ‘Correction needed with this article’ posted 28/10/2014 - by Justyna K, GaBI Online Editorial Office

Dear Dr Joung, Thank you very much for your valuable comments and the information provided. Upon checking, we confirm your information and we have updated the article with the current data accordingly. We appreciate very much your kind feedback, and please continue with your valuable comments to GaBI Online. Thank you and regards, Justyna

Correction needed with this article posted 23/09/2014 - by Jeewon Joung, MFDS, Republic of Korea

I would like to point out that Neurapeg is NOT a biosimilar product. It has different structure with original peg filgrastim. Neurapeg was authorized as "STAND ALONE" product in Korea. Furthermore, biosimilar approval in Korea is quite SIMILAR to EU and WHO guideline. MFDS requires full comparablity data in quality, safety, efficacy study with original product(reference product). Please be more cautious on writing this type of article.