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Biosimilars approved in Australia

Last update: 22 May 2015

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

Biosimilars Forum launched

A group of biosimilars developers in the US announced on 5 May 2015 the launch of a joint initiative to promote biosimilars in the form of the Biosimilars Forum.

Australian guide to biosimilars

Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provide a concise, ‘user-friendly’ reference on the subject for patients, clinicians, pharmacists, politicians and policymakers.

WHO receives positive feedback on BQ for biologicals

According to the World Health Organization’s executive summary of its 59th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances, almost half of comments on its proposed biological qualifier (BQ) for naming biologicals were positive.

Generics group established first voice for biosimilars in Canada

The Canadian Generic Pharmaceutical Association (CGPA), which represents Canada’s generics industry, announced on 7 April 2015 that it had set up a new CGPA Biosimilars Board, with Mr Michel Robidoux, President and General Manager of Sandoz Canada, as its inaugural Chair.

Arguments for same INN for biosimilars presented at WHO meeting

The World Health Organization recently held its 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals, including biosimilars was once again discussed.

Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators

The Dutch Medicines Evaluation Board (MEB) has updated its position on biosimilars, stating that ‘biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned’.

Biosimilars approved in South Korea

Last update: 10 April 2015

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.

Rheumatologists want to evaluate long-term safety of biosimilars

One of the biggest challenges for biosimilar companies is to convince physicians to use biosimilars instead of their well-known biological counterparts. One of the issues that physicians see as a concern is the long-term safety of biosimilars, a concern that is thought could slow down the adoption of biosimilars. This issue has even prompted certain organizations to embark on programmes that seek to provide definitive evidence on the issue.

Biosimilars of filgrastim

Filgrastim is a granulocyte colony-stimulating factor (G-CSF). Filgrastim treatment can be used to stimulate the bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.

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