Last update: 24 October 2023
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 35 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
|
| Adalimumab BS [adalimumab biosimilar 2]
|
|
Ankylosing spondylitis
Crohn’s disease
Entero-Behcet's Disease
Juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Psoriasis
|
22 Jan 2021
|
Daiichi Sankyo
|
| Adalimumab BS MA [adalimumab biosimilar 3]
|
adalimumab
|
Ankylosing spondylitis
Crohn’s disease
Entero-Behcet's Disease
Juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Psoriasis
|
23 Mar 2021
|
LG Chem/ Mochida Pharmaceutical
|
Agalsidase Beta BS [JCR]
[agalsidase beta biosimilar 1]
|
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
|
Bevacizumab BS
[bevacizumab biosimilar 3]
|
bevacizumab
|
Metastatic colorectal cancer
|
27 Sep 2022
|
Celltrion
|
| Darbepoetin alfa [KKF]
|
darbepoetin alfa
|
Anaemia
|
15 Aug 2018
|
Kyowa Hakko Kirin
|
| Darbepoetin alfa (CKD‑11101)
|
darbepoetin alfa
|
Anaemia
|
4 Dec 2018
|
Chong Kun Dang Pharmaceutical
|
Darbepoetin alfa BS
[darbepoetin alfa biosimilar 1]
|
darbepoetin alfa
|
Anaemia
|
20 Sep 2020
|
JCR Pharmaceuticals
|
Darbepoetin alfa BS
[darbepoetin alfa biosimilar 2]
|
darbepoetin alfa
|
Anaemia
|
20 Sep 2020
|
Sanwa Kagaku Kenkyusyo
|
Darbepoetin alfa BS
[darbepoetin alfa biosimilar 3]
|
darbepoetin alfa
|
Anaemia
|
20 Sep 2019
|
Mylan
|
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 biosimilar 2]
|
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 aspart BS
[insulin aspart biosimilar 1]
|
insulin aspart
|
Diabetes
|
23 Mar 2021
|
Sanofi
|
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]
|
Insulin lispro BS
[insulin lispro biosimilar 1]
|
insulin lispro
|
Diabetes
|
25 Mar 2020
|
Sanofi
|
Ranibizumab BS
[ranibizumab biosimilar 1]
|
ranibizumab
|
Age-related macular degeneration
|
27 Sep 2021
|
Senju Pharmaceutical
|
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 2020
|
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
|
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
|
Ustekinumab BS
[ustekinumab biosimilar 1]
|
ustekinumab
|
plaque psoriasis
psoriatic arthritis
|
Sep 2023
|
Alovotech/Fuji Pharma
|
|
*Data collected on 28 January 2014, updated on 24 October 2023.
**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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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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