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Biosimilars approved in Japan Posted 07/03/2014

Last update: 14 December 2018

In Japan, the regulatory body for the approval of medicines, including biologicals, is the Ministry for Health Labour and Welfare (MHLW).

The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese regulatory agency, working together with MHLW. PMDA’s Office of Biologicals provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines, including biosimilars.

In March 2009, guidelines for biosimilars, based on the European Union’s existing processes, were published by the MHLW [1].

These guidelines consider biosimilar drugs to be those products that are equivalent and homogenous to the reference biological product in terms of efficacy, quality and safety.

The first biosimilar to receive approval in Japan was Sandoz’s growth hormone treatment Somatropin BS (somatropin) in June 2009. To date, the PMDA has approved 18 biosimilars, within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoiesis stimulating agent, insulin and tumour necrosis factor (TNF)-inhibitor, for use in Japan, see Table 1.

Table 1: PMDA approved biosimilars*

Product name 
[JAN]

Active substance

Therapeutic area**

Authorization date

Manufacturer/Company name

Agalsidase Beta BS [JCR]

agalsidase beta

Fabry disease

28 Nov 2018

JCR Pharmaceuticals

Darbepoetin alfa injection syringe [KKF]

Darbepoetin alfa

Anaemia

15 Aug 2018

Kyowa Hakko Kirin

Darbepoetin alfa (CKD‑11101)

Darbepoetin alfa

Anaemia

4 Dec 2018

Chong Kun Dang Pharmaceutical

Epoetin alfa BS
[epoetin alfa biosimilar 1]

epoetin alfa

Anaemia
Renal anaemia

20 Jan 2010

JCR Pharmaceuticals

Etanercept BS [etanercept biosimilar 1

etanercept

Juvenile idiopathic arthritis
Rheumatoid arthritis

19 Jan 2018

Mochida Pharmaceutical

Filgrastim BS
[filgrastim biosimilar 1]

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

21 Nov 2012

Fuji Pharma/ Mochida Pharmaceutical

Filgrastim BS
[filgrastim biosimilar 3] 

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

24 Mar 2014

Sandoz

Filgrastim BS
[filgrastim biosimilar 2] 

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

28 Feb 2013

Teva Pharma Japan/Nippon Kayaku

Herzuma

trastuzumab

Gastric cancer

Mar 2018

Celltrion//Nippon Kayaku

Infliximab BS
(Remsima)
[infliximab biosimilar 1]

infliximab

Crohn’s disease
Rheumatoid arthritis
Ulcerative colitis

4 Jul 2014

Celltrion/Nippon
Kayaku

Infliximab BS
(Remsima)
[infliximab biosimilar 2]

infliximab

Crohn’s disease
Rheumatoid arthritis
Psoriasis
Ulcerative colitis

27 Sep 2017

Nichi-Iko Pharmaceutical/ Yakuhan Pharmaceutical [2]

Infliximab BS
(Remsima)
[infliximab biosimilar 3]

infliximab

Crohn’s disease
Rheumatoid arthritis
Psoriasis
Ulcerative colitis

2 Jul 2018

Pfizer Japan [3]

Insulin glargine BS
[insulin glargine biosimilar 1] 

insulin glargine

Diabetes

26 Dec 2014

Eli Lilly/Boehringer Ingelheim [4]

Insulin glargine BS
[insulin glargine biosimilar 2] 

insulin glargine

Diabetes

28 Mar 2016

Biocon/Fujifilm Pharma [5]

Rituximab BS
 [rituximab biosimilar 1]

rituximab

B-cell non-Hodgkin’s lymphoma
B-cell lymphoproliferative disorder
Microscopic polyangiitis
Wegener's granulomatosis

27 Sep 2017

Sandoz

Somatropin BS

somatropin

Growth hormone deficiency
Turner syndrome

22 Jun 2009

Sandoz

Trastuzumab BS
 [trastuzumab biosimilar 1]

trastuzumab

HER2+ gastric cancer

23 Mar 2018

Celltrion

Trastuzumab BS [trastuzumab biosimilar 2]

trastuzumab

HER2+ gastric cancer

21 Sep 2018

Daiichi Sankyo

*Data collected on 28 January 2014, updated on 14 December
**Therapeutic area taken from company information, from originator product information on EMA website or from PMDA information

[ ] = Japanese Approved Name (JAN)

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Sandoz applies for Japanese approval for biosimilar G-CSF

Biosimilars approved in Europe

References
1.  GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 1]. Available from: www.gabionline.net/Guidelines/Japanese-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Nichi-Iko gains Japanese approval for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 5]. Available from: www.gabionline.net/Biosimilars/News/Nichi-Iko-gains-Japanese-approval-for-infliximab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Pfizer gains Japanese approval for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Aug 24]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-gains-Japanese-approval-for-infliximab-biosimilar 
4.  GaBI Online - Generics and Biosimilars Initiative. Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 6]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-insulin-glargine-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. Biocon receives Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 22]. Available from: www.gabionline.net/Biosimilars/News/Biocon-receives-Japanese-approval-for-insulin-glargine-biosimilar

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Source: PMDA

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