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Inflammatory arthritis: auditioning for the role of biosimilar Biosimilars/Research | Posted 28/02/2014

Targeted biological therapies have proven themselves highly effective in the treatment of inflammatory joint diseases, but their benefits are restricted by cost. Biosimilars of these therapies woul...

Compliance and persistence same for generic and brand-name alendronate Generics/Research | Posted 28/02/2014

A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1].

FDA starts widespread testing of generics Generics/General | Posted 28/02/2014

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.

Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’ Biosimilars/News | Posted 28/02/2014

India-based biologicals specialist Biocon and US generics maker Mylan have challenged the Delhi High Court’s interim order that barred them from using Switzerland-based drug giant Roche’s data to s...

FDA and Health Canada streamline drug submissions Policies & Legislation | Posted 28/02/2014

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug autho...

Merck and Samsung Bioepis collaborate on biosimilar insulin Biosimilars/News | Posted 28/02/2014

US pharma giant Merck and Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis, announced on 10 February 2014 that they had expanded their collaboration with an agreemen...

New Zealand guidelines for biosimilars Guidelines | Posted 28/02/2014

Last update:  28 February 2014The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsibl...

France to allow biosimilars substitution Policies & Legislation | Posted 21/02/2014

Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course of treatment and tha...