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Trastuzumab and agalsidase beta biosimilars launched in Japan Posted 11/01/2019

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Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.

Daiichi Sankyo announced that it had launched its trastuzumab biosimilar [trastuzumab biosimilar 2] for intravenous drip infusions in doses of 60 mg and 150 mg in Japan.

Daiichi Sankyo received approval from Japan’s MHLW in September 2018 [1]. The product is a biosimilar of Roche’s Herceptin (trastuzumab) and was developed by Amgen. Daiichi Sankyo made a deal with US-based biologicals specialist Amgen in July 2016 for several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab [2].

The product is the first biosimilar launched by Daiichi Sankyo. The company is responsible for the distribution and commercialization of the product in Japan and Amgen remains responsible for its manufacture.

JCR Pharmaceuticals (JCR) announced that its agalisidase beta biosimilar (agalsidase beta BS) in doses of 5 mg and 35 mg was being placed on the National Health Insurance (NHI) reimbursement price list and was being launched in Japan.

JCR applied for Japanese regulatory approval for its agalsidase beta biosimilar, JR‑051, in September 2017 [3] and received approval from Japan’s regulatory agency, the Ministry for Health Labour and Welfare (MHLW), in September 2018.

JCR says that JR‑051 is not only the company’s ‘first enzyme replacement therapy (ERT) product for lysosomal storage disorders (LSDs), but also the first domestic therapeutic enzyme for LSDs based on serum-free culture technology’. The product is a proposed biosimilar version of Genzyme’s Fabry disease treatment Fabrazyme (agalsidase beta). Fabry disease is an inherited disease caused by the lack of an enzyme called alpha-galactosidase A, in the body. The rare disease is characterized by pain in the extremities, clouding of the cornea, renal failure and cardiac dysfunction. Approximately 600 patients in Japan and 10,000 worldwide suffer from the disease, according to JCR.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Originator biologicals and biosimilars under attack in UK and Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 11]. Available from: www.gabionline.net/Biosimilars/General/Originator-biologicals-and-biosimilars-under-attack-in-UK-and-Japan
2. GaBI Online - Generics and Biosimilars Initiative. Amgen and Daiichi Sankyo make deal for biosimilars in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 11]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Daiichi-Sankyo-make-deal-for-biosimilars-in-Japan
3. GaBI Online - Generics and Biosimilars Initiative. JCR files for Japanese approval of agalsidase beta biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 11]. Available from: www.gabionline.net/Biosimilars/News/JCR-files-for-Japanese-approval-of-agalsidase-beta-biosimilar

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Source: Daiichi Sankyo, JRC

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