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Amgen launches biosimilars info app posted 21/11/2014

Biologicals major Amgen has launched an app which aims to provide a source of information about biosimilars.

Amgen sues Sandoz over filgrastim biosimilar posted 14/11/2014

Biologicals major Amgen is suing Sandoz to stop the biosimilars maker from marketing a biosimilar of its top-selling product...

Study into switching from Aranesp to biosimilar epoetin alfa posted 10/11/2014

Biologicals major Amgen has started recruiting patients for a clinical trial to study the effect of switching patients from t...

Coherus sells shares to raise funds for biosimilars programme posted 10/11/2014

US-based biosimilars developer Coherus BioSciences (Coherus) is looking for further funding for its biosimilar programme. The...

LG Life Sciences and Mochida make deal for adalimumab biosimilar posted 10/11/2014

South Korea-based LG Life Sciences and Japan-based Mochida Pharmaceutical (Mochida) announced on 15 October 2014 that they ha...

 

Research

Extrapolation of indications in biosimilars: filgrastim posted 21/11/2014

Extrapolation* of indications for biosimilars is a contentious issue and has been met with concern by physicians. Members of...

Biosimilars: when indications can be extrapolated posted 14/11/2014

Extrapolation* is already a well-established and accepted scientific and regulatory principle, according to members of the Eu...

Predicting the response of diabetes patients to biosimilar insulin posted 13/11/2014

For patients with type 1 diabetes, the quality of the insulin they take is a matter of life and death. The situation is simil...

Biosimilars: similar but not identical posted 13/11/2014

One reason for distrust among physicians over using biosimilars in extrapolated* indications could be the fact that it is fre...

Improved labelling sought for biosimilar acceptance posted 13/11/2014

The terms of approval for every biosimilar and its reference product must be made clearer, argue the European Biopharmaceutic...

 

General

More discussion over WHO biological qualifier posted 21/11/2014

The World Health Organization recently held its 59th Consultation on International Nonproprietary Names (INN) for Pharmaceuti...

Biosimilars approved in South Korea posted 21/11/2014

Last update: 21 November 2014In South Korea, the regulatory body for the approval of medicines, including biologicals and bio...

Subsequent entry biologics approved in Canada posted 17/11/2014

Last update: 14 November 2014 In Canada, the regulatory body for the approval of medicines is the Therapeutic Products D...

Biosimilars approved in Europe posted 14/11/2014

Last update: 14 November 2014 In the European Union (EU), a legal framework for approving biosimilars was established in...

Biosimilars of etanercept posted 14/11/2014

Last update: 7 November 2014Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis fac...

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