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FDA to tighten control over generics Policies & Legislation | Posted 23/11/2012

A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking mo...

ABPI issues position paper on biosimilars Biosimilars/General | Posted 23/11/2012

The Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies in the UK, announced on 12 November 2012 the publication of its...

Alleviating concerns around generic antiepileptic medications Generics/Research | Posted 23/11/2012

Reports that some patients with epilepsy were more likely to experience seizures and hospitalisation after switching from brand-name drugs to generic alternatives have led to concerns about generic...

Major shake-up of API import rules in Europe Policies & Legislation | Posted 23/11/2012

EU is seeking to impose good manufacturing practice (GMP) standards throughout the world in an attempt to stop the import of counterfeit or substandard active pharmaceutical ingredients (APIs) for...

Biosimilars approved and marketed in Germany Biosimilars/General | Posted 23/11/2012

Last updated: 23 November 2012 The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) is responsible for the approval, i.e. marketing...

Generics competition for Pfizer’s sildenafil Generics/News | Posted 23/11/2012

Apotex Corporation, Dr Reddy’s Laboratories, Mylan, Torrent Pharmaceuticals and Watson Laboratories have all received FDA approval for bioequivalent generic versions of Pfizer’s Revatio (sildenafil...

Saving money in the European healthcare system with biosimilars Biosimilars/Research | Posted 16/11/2012

Biotechnology-derived medicines are increasingly popular for treating a range of conditions from cancer to autoimmunity, and yet they are among the most expensive healthcare products owing to their...

Dialogue needed to build confidence in biosimilars Biosimilars/Research | Posted 16/11/2012

Concerns about the safety and efficacy of biosimilars have led many healthcare professionals to become reluctant to prescribe these products for their patients [1]. According to a commentary by Dr...