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Biosimilars approved in Japan

SUBMIT

Posted 07/03/2014

Last update: 14 October 2016


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

Biosimilars

The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese regulatory


agency, working together with MHLW. PMDAs Office of Biologicals provides consultations
concerning the clinical trials of new drugs and medical devices and handles biotechnology
medicines, including biosimilars.

NEWS

In March 2009, guidelines for biosimilars, based on the European Unions 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 Sandozs growth hormone treatment Somatropin BS (somatropin) in June
2009. To date, the PMDA has approved seven biosimilars within the product classes of human growth hormone, granulocyte
colony-stimulating factor, erythtropoesis 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

Epoetin alfa BS
[epoetin alfa
biosimilar 1]

epoetin alfa

Anaemia
Renal anaemia

20 Jan 2010

JCR Pharmaceuticals

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

Infliximab BS
(Remsima)
[infliximab
biosimilar 1]

infliximab

Crohns disease
Rheumatoid arthritis
Ulcerative colitis

4 Jul 2014

Celltrion/Nippon
Kayaku

Insulin glargine
BS
[insulin glargine
biosimilar 1]

insulin
glargine

Diabetes

26 Dec 2014

Eli Lilly/Boehringer Ingelheim [2]

Insulin glargine
BS
[insulin glargine
biosimilar 2]

insulin
glargine

Diabetes

28 Mar 2016

Biocon/Fujifilm Pharma [3]

Nesp

darbepoetin
alfa

Anemia
Cancer
Chronic kidney failure

13 Sep 2013

Kyowa Hakko Kirin

Somatropin BS

somatropin

Growth hormone deficiency


Turner syndrome

22 Jun 2009

Sandoz

FDA accepts application


for pegfilgrastim
biosimilar from Coherus
Baxalta and Momenta
part ways on adalimumab
biosimilar

RESEARCH

Trials for biosimilar


etanercept
Differences in efficacy
assessment in clinical
trials for biosimilars

*Data collected on 28 January 2014, updated on 14 October 2016;


** 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/Japaneseguidelines-for-biosimilars
2. 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
3. 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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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.
Source: PMDA
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