Biosimilars approved in Japan

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).

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).

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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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Source: PMDA