Biosimilars approved in Japan

Published: 2014-10-02

Biosimilars approved in Japan

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, Japan has approved six biosimilars within the product classes of human growth hormone and granulocyte colony-stimulating factor, for use in Japan, see Table 1.

Table 1: PMDA approved biosimilars*

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/Company name

Epoetin alfa BS

epoetin alfa

Anaemia
Renal anaemia

20 Jan 2010

JCR Pharmaceuticals

Filgrastim BS

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

21 Nov 2012

Fuji Pharma

Filgrastim BS

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

24 Mar 2014

Sandoz

Filgrastim BS

filgrastim

Cancer
Haematopoietic stem cell transplantation
Neutropenia

28 Feb 2013

Teva Pharma Japan

Remsima

infliximab

Ankylosing spondylitis
Crohn’s disease
Psoriatic arthritis
Psoriasis
Rheumatoid arthritis
Ulcerative colitis

4 July 2014

Celltrion/Nippon
Kayaku

Somatropin BS

somatropin

Growth hormone deficiency
Turner syndrome

22 Jun 2009

Sandoz

*Data collected on 1 August 2014
Source: Celltrion, PMDA, Sandoz

Related articles

Japan approves second biosimilar G-CSF

Sandoz applies for Japanese approval for biosimilar G-CSF

Biosimilars approved in Europe

Reference

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

Source: www.gabionline.net

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