Home / Biosimilars / General / Biosimilars approved in Japan

Biosimilars approved in Japan 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).

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 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

Crohn’s 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

*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/Japanese-guidelines-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

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. 

Source: PMDA

Comments (0)

Generics News Research General

more

Biosimilars News Research General

more