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Biosimilars knowledge gap needs addressing

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars.

WHO investigates use of a biological qualifier for biosimilars

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances.

Subsequent entry biologics approved in Canada

Last update: 11 February 2014 

In Canada, the regulatory body for the approval of medicines is the Therapeutic Products Directorate of Health Canada.

Biosimilars approved in Japan

Last update: 4 April 2014

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

GPhA proposes using manufacturer names to distinguish biosimilars

The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end the dispute over how to assign international non-proprietary names (INNs) to biosimilars in the US.

Biosimilars approved in South Korea

Last update: 14 March 2014

In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.

EU majority says same INNs for biosimilars

According to recently published summary minutes from an October 2013 meeting of the European Commission’s Pharmaceutical Committee, the majority of EU Member States agree that biosimilars should have the same international non-proprietary name (INN) as their reference biological.

Biosimilars approved in Australia

Last update: 21 February 2014 

In Australia, the legal framework for approving medicines was established via the Therapeutic Goods Act 1989.

Teva gains FDA approval for three-times-a-week Copaxone

Teva Pharmaceutical Industries (Teva) announced on 28 January 2013 the generics giant had gained US Food and Drug Administration (FDA) for a new formulation of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Biosimilars developments during 2013

Last update: 12 February 2014 

The past year has been a busy one for the biosimilars’ industry. One of the most important milestones during 2013 was the European approval of the first monoclonal antibody biosimilar infliximab [Remsima/Inflectra] made as a collaboration by South Korean biotechnology company Celltrion and US-based generics major Hospira [1]. Celltrion has also gained approval for Remsima in South Korea [2] and Colombia [3], and has also applied for approval in Japan [4]. In fact, in Europe, the European Medicines Agency (EMA) has been busy during 2013 approving five biosimilars [5, 6].

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