Nippon Kayaku has received the second G-CSF biosimilar approval in Japan

March 7, 2013 8:58 AM

Nippon Kayaku Co., Ltd. has received the manufacturing and marketing authorization for recombinat human granulocyte colony stimulating factor (G-CSF) product named Filgrastim BS “NK” which was proceeding with the development jointly with Kowa Teva Co., Ltd. [the present Teva Pharmaceuticals Co. Ltd.] on February 28th, 2013.

Filgrastim BS “NK” (syringe of 75mcg, 150mcg, 300mcg for injection) is the Follow-on Biologics of the filgrastim (recombination) and with the medicine manufacturing which uses the bulk drug which is the same as biosimilar ( the name of the follow-on biologics in the Europe ) which Teva Phamaceuticals industries limited sells in European countries, the approval in Japan becomes the 40th country following the Europe and the U.S..

The Follow-on Biologics of the filgrastim is as well as the originator act on the granulocyte-committed progenitors and promote their differentiation and proliferation, and further it promotes the release of the neutrophil from the bone marrow and its function.  In the field of anti-cancer therapy, it is mainly applied to the treatment of neutropenia induced by anti- cancer chemotherapy.

Nippon Kayaku provides medical products and related items 28 brands by 26 kinds of anti-cancer drugs and its related products are already in the field of cancer treatment.  Also, Filgrastim BS “NK” approved this time is the product newly developed as one of the related products, and this product will be the first biosimilar for the company.

Future, the company plans to earnestly promote the domestic development of biosimilars following this product, and wants to  continue to strive to contribute even more for everybody patients and their families, medical personnel in the medical field, such as cancer.


Source: Nippon Kayaku press release

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