Guidelines

FDA issues guidance on self-identification for generics makers

Home/Guidelines | Posted 04/11/2016

The US Food and Drug Administration (FDA) announced on 22 September 2016 that it had published a guidance document clarifying its expectations on self-identification for generics makers.

Regulations for biosimilars in South Korea

Home/Guidelines | Posted 10/04/2015

The legislative basis for the regulation of biosimilars and its guideline for evaluation of biosimilars in South Korea was established in 2009 [1, 2].

Naming requirements in Australian biosimilars guidance

Home/Guidelines | Posted 04/10/2013

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), published specific guidance for biosimilars on its website on 30 July 2013. Included in this guidance is a section on naming conventions for biosimilars.

Australia issues new biosimilars guidance

Home/Guidelines | Posted 23/08/2013

Australia’s regulatory body, the Therapeutic Goods Administration (TGA) published specific guidance for biosimilars on its website on 30 July 2013.

Development and regulation of biosimilars in Japan

Home/Guidelines | Posted 16/08/2013

In Japan, a biosimilar product is defined as a biotechnological drug product developed by a different company that is comparable to the approved biotechnology-derived product (reference product) of an innovator company [1, 2].

South Korean guidelines for biosimilars

Home/Guidelines | Posted 09/03/2012

Last update:  10 April 2015

The regulatory body for approval of medicines in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration. The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the South Korea.

ACR asked for guidelines on biosimilar substitution

Home/Guidelines | Posted 28/10/2016

At the US Food and Drug Administration’s (FDA) latest meeting on Biosimilar User Fee Act Reauthorization (BsUFA II), the American College of Rheumatology (ACR) asked FDA to create guidelines for biosimilar substitution.

Japanese guidelines for biosimilars

Home/Guidelines | Posted 06/06/2011

Last update: 21 October 2016

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.

Australia to adopt EMA generics guidelines

Home/Guidelines | Posted 07/10/2016

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.

FDA releases new bioequivalence guideline for fidaxomin generics

Home/Guidelines | Posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 29 August 2016 that it had released a new draft guidance document for generics of fidaxomicin.