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Biosimilar substitution in the EU Biosimilars/Research | Posted 04/03/2011

Although many things—including regulations for licensing of biosimilars—are harmonised within the EU, the attitude towards biosimilars and their substitution within the different countries of the E...

Impact of generic substitution in Finland Generics/Research | Posted 04/03/2011

Mandatory generic substitution was introduced in Finland on 1 April 2003. A recent study compared the impact of generic substitution on both originator and generic pharmaceutical companies in Finland.

The biggest US patent expiries of 2010 Generics/General | Posted 04/03/2011

While the much talked-about patent cliff will not hit until 2011, 2010 has been witness to patent expirations of some of the industry’s blockbuster drugs.

Spectrum to develop biosimilar monoclonal antibody Biosimilars/News | Posted 04/03/2011

California-based Spectrum Laboratories announced on 5 January 2011 that it has signed an agreement with contract research organisation Viropro for the development of a biosimilar version of Roche’s...

European Commission to investigate patent settlements again Generics/General | Posted 04/03/2011

The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between...

New ANDAs and patent challenges for Impax Laboratories Generics/News | Posted 04/03/2011

Impax Laboratories is facing a whole barrage of patent litigation following its latest Abbreviated New Drug Application (ANDA) filings and approvals with the FDA.

Perrigo buys Paddock for US$540 million Pharma News | Posted 04/03/2011

Perrigo Company may not be a household name, but nevertheless life is exciting for a medium-sized company in the pharmaceuticals world. Undeterred by a pending FDA warning letter about its Michigan...

Exclusivity for biological drugs in the US: what now Policies & Legislation | Posted 25/02/2011

Drugmakers have been embroiled in an epic battle over the length of the exclusivity period that biological drugs can enjoy before generic competition. Everyone from legislators to senators to healt...