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Philippines urged to import drugs from Bangladesh Pharma News | Posted 10/05/2013

The Prime Minister of Bangladesh, Ms Sheikh Hasina, on 5 May 2013 urged the Philippines to import pharmaceutical products from Bangladesh, particularly for the countries governmental hospitals and...

Sanofi starts biosimilar insulin trials Biosimilars/News | Posted 10/05/2013

Pharma giant Sanofi confirmed in its 2013 Q1 business report that its biosimilar insulin projects have entered into phase I of clinical development as planned. Sanofi intends to develop these...

Valeant deal to acquire Actavis on hold Pharma News | Posted 10/05/2013

Drugmaker Valeant Pharmaceuticals International (Valeant) was in talks to acquire generics manufacturer Actavis for more than US$13 billion, in what would rank as one of the biggest healthcare deal...

Intas launches rituximab ‘similar biologic’ in India Biosimilars/News | Posted 10/05/2013

India-based generics company Intas Pharmaceuticals (Intas) announced the launch of a ‘similar biologic’ – as the Indian regulatory authorities call these products –version of rituximab in India.

Generics makers to self-identify for FY2014 generics fees Policies & Legislation | Posted 10/05/2013

FDA has informed generics and active pharmaceutical ingredient (API) manufacturers that they will have one month to self-identify for the generics drug user fees for fiscal year (FY) 2014.

EMA publishes concept paper on extrapolation Policies & Legislation | Posted 03/05/2013

EMA published a concept paper on extrapolation of efficacy and safety in drug development in April 2013. The publication of the concept paper comes at a time when extrapolation for biosimilars is a...

Development of biosimilars for rheumatology Biosimilars/Research | Posted 03/05/2013

In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US...

EU publishes consensus report on biosimilars Reports | Posted 03/05/2013

The European Commission’s (EC’s) Enterprise and Industry Directorate-General has published a new report providing comprehensive information on the concept of biosimilars.