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

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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

Source URL: https://gabi-journal.net/news/biosimilars-approved-in-japan