Biosimilars approved in Japan

Biosimilars/General | Posted 07/03/2014 post-comment0 Post your comment

Last update: 12 March 2021

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

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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 27 biosimilars, within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoiesis stimulating agent, insulin, angiogenesis inhibitor 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
Adalimumab BS [adalimumab biosimilar 1] adalimumab Ankylosing spondylitis
Crohn’s disease
Entero-Behcet's Disease
Juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Psoriasis
29 Jun 2020 Fujifilm Kyowa Kirin Biologics
Agalsidase Beta BS [JCR] agalsidase beta Fabry disease 28 Nov 2018 JCR Pharmaceuticals
Bevacizumab BS
[bevacizumab biosimilar 1]
bevacizumab  Colorectal cancer 18 Jun 2019 Pfizer Japan
Bevacizumab BS
[bevacizumab biosimilar 2]
bevacizumab  Colorectal cancer 20 Sep 2019 Daiichi Sankyo
Darbepoetin alfa BS
[darbepoetin alfa biosimilar 1]
darbepoetin alfa Anaemia 20 Sep 2019 JCR Pharmaceuticals
Darbepoetin alfa BS
[darbepoetin alfa biosimilar 2]
darbepoetin alfa Anaemia 20 Sep 2019 Sanwa Kagaku Kenkyusyo
Darbepoetin alfa BS
[darbepoetin alfa biosimilar 3]
darbepoetin alfa Anaemia 20 Sep 2019 Mylan
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
Etanercept (YLB113) etanercept Juvenile idiopathic arthritis Rheumatoid arthritis 26 Mar 2019 Kyowa Pharmaceutical Industry [YL Biologics (Lupin/ Yoshindo)]  
Filgrastim BS
[filgrastim biosimilar 1]
filgrastim Cancer
Haematopoietic stem cell transplantation
Neutropenia
21 Nov 2012 Fuji Pharma/ Mochida Pharmaceutical
Filgrastim BS
[filgrastim biosimilar 2] 
filgrastim Cancer
Haematopoietic stem cell transplantation
Neutropenia
28 Feb 2013 Teva Pharma Japan/Nippon Kayaku
Filgrastim BS
[filgrastim biosimilar 3] 
filgrastim Cancer
Haematopoietic stem cell transplantation
Neutropenia
24 Mar 2014 Sandoz
Herzuma trastuzumab Gastric cancer 1 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
Rituximab BS
[rituximab biosimilar 2]
rituximab B-cell non-Hodgkin’s lymphoma
B-cell lymphoproliferative disorder
Microscopic polyangiitis
Wegener's granulomatosis
20 Sep 2019 Pfizer Japan
Somatropin BS somatropin Growth hormone deficiency
Turner syndrome
22 Jun 2009 Sandoz
Teriparatide BS   
[teriparatide biosimilar 1]
teriparatide Osteoporosis 20 Sep 2019 Mochida Pharmaceutical
Trastuzumab BS
[trastuzumab biosimilar 1]
trastuzumab

HER2+ gastric cancer

HER2+ breast cancer

23 Mar 2018 Celltrion
Trastuzumab BS
[trastuzumab biosimilar 2]
trastuzumab HER2+ gastric cancer 21 Sep 2018 Daiichi Sankyo
Trastuzumab BS
[trastuzumab biosimilar 3]
trastuzumab HER2+ gastric cancer 21 Sep 2018 Pfizer Japan

*Data updated on 12 March 2021.
**Therapeutic area taken from company information, from originator product information on EMA website or from PMDA information

[ ] = Japanese Approved Name (JAN).

Related articles
Japan approves second biosimilar G-CSF

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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