Sandoz Receives Japanese Approval for Biosimilar Filgrastim

Sandoz announced that Sandoz Japan has received marketing authorization approval for its biosimilar filgrastim (Kyowa Hakko Kirin’s GRAN®). The product, which will be marketed as Filgrastim BS Injection 75 µg/150 µg/ 300 µg Syringe “Sandoz”, is the second Sandoz biosimilar to be approved in Japan. 

Filgrastim is used with certain cancer patients to accelerate recovery of infection-fighting white blood cells after chemotherapy (prevention of neutropenia) and is also used to stimulate mobilization of hematopoietic stem cells for collection and transplantation. Sandoz Filgrastim is approved in Japan for the same range of indications as the reference product GRAN and offers patients comparable quality, safety and efficacy combined with potentially greater cost-effectiveness for the healthcare system.

"We are pleased to receive our second biosimilar approval in Japan," said Junichi Nakamichi, Country Head, Sandoz Japan. "This product has already been used in clinical practice in over 40 countries around the world under the brand name of Zarzio® and we look forward to making this product available to patients and physicians in Japan."

Zarzio is the number one biosimilar filgrastim globally and in 2013 it became the most prescribed Daily GCSF treatment in Europe ahead of originator products from Amgen and Chugai.

Sandoz is the only company with marketing authorization for more than one biosimilar medicine in the Japanese market. In 2009, the company’s human growth hormone Omnitrope® (Pfizer’s Genotropin®) became the first-ever biosimilar medicine to be approved and launched in Japan.

Sandoz is the global leader and pioneer in developing, manufacturing and commercializing biosimilars. Sandoz markets three biosimilar products, all of which are #1 in their respective categories globally. Sandoz’ biosimilars are collectively sold in over 50 countries and have generated over 100 million patient exposure days of experience. Sandoz has an industry-leading biosimilars pipeline with six molecules in the Phase III clinical trials/registration prep stage including biosimilar versions of leading biologics such as adalimumab (AbbVie’s Humira®), etanercept (Amgen’s Enbrel®) and rituximab (Roche’s Rituxan®/MabThera®).