Biosimilars approved in Japan Posted 07/03/2014
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 29 Jun 2020 Fujifilm Kyowa Kirin Biologics Agalsidase Beta BS [JCR] agalsidase beta Fabry disease 28 Nov 2018 JCR Pharmaceuticals
Bevacizumab BS bevacizumab Colorectal cancer 18 Jun 2019 Pfizer Japan
Bevacizumab BS bevacizumab Colorectal cancer 20 Sep 2019 Daiichi Sankyo
Darbepoetin alfa BS darbepoetin alfa Anaemia 20 Sep 2019 JCR Pharmaceuticals
Darbepoetin alfa BS darbepoetin alfa Anaemia 20 Sep 2019 Sanwa Kagaku Kenkyusyo
Darbepoetin alfa BS 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
Anaemia 20 Jan 2010 JCR Pharmaceuticals
Etanercept BS etanercept
Juvenile idiopathic 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
Cancer 21 Nov 2012 Fuji Pharma/ Mochida Pharmaceutical
Filgrastim BS filgrastim
Cancer 28 Feb 2013 Teva Pharma Japan/Nippon Kayaku
Filgrastim BS filgrastim
Cancer 24 Mar 2014 Sandoz Herzuma trastuzumab Gastric cancer 1 Mar 2018 Celltrion//Nippon Kayaku
Infliximab BS infliximab
Crohn’s disease 4 Jul 2014
Celltrion/Nippon
Infliximab BS infliximab
Crohn’s disease 27 Sep 2017 Nichi-Iko Pharmaceutical/ Yakuhan Pharmaceutical [2]
Infliximab BS infliximab
Crohn’s disease 2 Jul 2018 Pfizer Japan [3]
Insulin glargine BS insulin glargine Diabetes 26 Dec 2014 Eli Lilly/Boehringer Ingelheim [4]
Insulin glargine BS insulin glargine Diabetes 28 Mar 2016 Biocon/Fujifilm Pharma [5]
Rituximab BS rituximab
B-cell non-Hodgkin’s lymphoma 27 Sep 2017 Sandoz
Rituximab BS rituximab
B-cell non-Hodgkin’s lymphoma 20 Sep 2019 Pfizer Japan Somatropin BS somatropin
Growth hormone deficiency 22 Jun 2009 Sandoz
Teriparatide BS teriparatide Osteoporosis 20 Sep 2019 Mochida Pharmaceutical
Trastuzumab BS trastuzumab HER2+ gastric cancer HER2+ breast cancer 23 Mar 2018 Celltrion
Trastuzumab BS trastuzumab HER2+ gastric cancer 21 Sep 2018 Daiichi Sankyo
Trastuzumab BS trastuzumab HER2+ gastric cancer 21 Sep 2018 Pfizer Japan
*Data updated on 12 March 2021. [ ] = Japanese Approved Name (JAN).
Related articles Sandoz applies for Japanese approval for biosimilar G-CSF Biosimilars approved in Europe
References Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.
Crohn’s disease
Entero-Behcet's Disease
Juvenile idiopathic arthritis
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Psoriasis
[bevacizumab biosimilar 1]
[bevacizumab biosimilar 2]
[darbepoetin alfa biosimilar 1]
[darbepoetin alfa biosimilar 2]
[darbepoetin alfa biosimilar 3]
[epoetin alfa biosimilar 1]
Renal anaemia
[etanercept biosimilar 1
Rheumatoid arthritis
[filgrastim biosimilar 1]
Haematopoietic stem cell transplantation
Neutropenia
[filgrastim biosimilar 2]
Haematopoietic stem cell transplantation
Neutropenia
[filgrastim biosimilar 3]
Haematopoietic stem cell transplantation
Neutropenia
(Remsima)
[infliximab biosimilar 1]
Rheumatoid arthritis
Ulcerative colitis
Kayaku
(Remsima)
[infliximab biosimilar 2]
Rheumatoid arthritis
Psoriasis
Ulcerative colitis
(Remsima)
[infliximab biosimilar 3]
Rheumatoid arthritis
Psoriasis
Ulcerative colitis
[insulin glargine biosimilar 1]
[insulin glargine biosimilar 2]
[rituximab biosimilar 1]
B-cell lymphoproliferative disorder
Microscopic polyangiitis
Wegener's granulomatosis
[rituximab biosimilar 2]
B-cell lymphoproliferative disorder
Microscopic polyangiitis
Wegener's granulomatosis
Turner syndrome
[teriparatide biosimilar 1]
[trastuzumab biosimilar 1]
[trastuzumab biosimilar 2]
[trastuzumab biosimilar 3]
**Therapeutic area taken from company information, from originator product information on EMA website or from PMDA information
Japan approves second biosimilar G-CSF
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
Source: PMDA