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Biosimilars applications under review by EMA – April 2014 Biosimilars/General | Posted 16/05/2014

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...

EMA and FDA report on collaborative efforts Policies & Legislation | Posted 16/05/2014

Key initiatives being undertaken between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) were discussed at a bilateral meeting which took place in London, UK,...

Celltrion files infliximab patent lawsuit in US Biosimilars/News | Posted 16/05/2014

South Korean biotechnology company Celltrion filed a lawsuit on 31 March 2014 in a federal court in Massachusetts seeking a declaratory judgement that Janssen Biotech’s (Janssen) remaining patents...

Blood pressure generics to be included in FDA’s testing plans Generics/News | Posted 16/05/2014

The US Food and Drug Administration (FDA) is planning an extensive study of blood-pressure drugs after receiving thousands of complaints from doctors and patients.

Pamplona investment group buys majority share in Alvolgen Pharma News | Posted 16/05/2014

Specialist investment manager Pamplona Capital Management (Pamplona) announced on 2 April 2014 that it had acquired a majority stake in US generics company Alvogen, one of the fastest growing gener...

Biosimilars for inflammatory bowel disease in Norway Biosimilars/Research | Posted 09/05/2014

Europe approved its first biosimilar monoclonal antibody Inflectra/Remsima (infliximab) on 10 September 2013 [1]. The biosimilar is now recommended by the Norwegian Drug Procurement Cooperation (LI...

Sandoz advances biosimilars pipeline Biosimilars/News | Posted 09/05/2014

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 28 April 2014 that it had reached several important milestones in the development of biosimilar etanercept, filgrastim and peg...

Generics applications under review by EMA – April 2014 Generics/General | Posted 09/05/2014

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centrali...