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Amgen starts phase III trial for biosimilar rituximab Biosimilars/News | Posted 26/09/2014

Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Phase III trials for generic asthma inhaler and insulin glargine Generics/News | Posted 26/09/2014

Generics giant Mylan is set to embark on phase III clinical trials of its generic fluticasone/salmeterol inhaler for asthma patients.

Biosimilars applications under review by EMA – August 2014 Biosimilars/General | Posted 26/09/2014

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval...

Roche updates position on biosimilars Biosimilars/News | Posted 26/09/2014

Originator pharma company Roche has updated its position statement on biosimilars, stating that ‘biosimilars are not quite the same’.

Generics taskforce for Australia Generics/General | Posted 26/09/2014

Australia’s Generic Medicines Industry Association (GMiA), which represents companies that manufacture, supply and export generics, has called on the country’s Minister for Industry to convene a Me...

Strategy for biosimilars in China Biosimilars/Research | Posted 26/09/2014

China is one of the largest pharmaceutical markets in the world, and has seen rapid growth in the biopharmaceuticals industry in recent years.  However, it is still lacking guidance when it co...

Concerns from EU and US over Colombian biologicals guidelines Guidelines | Posted 19/09/2014

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including 'productos...

Biosimilars of trastuzumab Biosimilars/General | Posted 19/09/2014

Last update: 21 April 2017Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of...