Tag Archives: European Union

Biosimilar Development in Europe: Ten Years On

The European Union established the first legal regulatory guidelines for biosimilars in 2005. The first biosimilar, Omnitrope, a version of somatropin, was approved in April 2006. To date, the EU has approved 19 applications in total (two were withdrawn after authorization so 17 are now marketed) and continues to update its guidelines, general and product-specific, […]
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EFPIA’s “Integrated Strategy”: Out of the Frying Pan, Into the Fire?

It’s difficult to open an email or an envelope in Brussels these days without yet another agenda falling out of it, carrying the promise of a new start. With a new European Parliament installed, a new European Commission president appointed and a new Commission on the way, and guarded optimism that the worst of the […]
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EMA Responds Robustly to Conflict-of-Interest Claims

By Philip Ward, Applied Clinical Trials. The European Medicines Agency (EMA) has insisted that the concerns raised about its scientific advice given to pharmaceutical companies stem from a flawed understanding of the activities of the agency and its partners in this area.
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European Pharma Policy Reaches "New Level of Timidity"

By Peter O’ Donnell, Applied Clinical Trials. The European Union has managed to snatch defeat from the jaws of opportunity once more! A long-heralded document portentously entitled “Pharmaceutical industry: a strategic sector for the European economy,” and supposedly initiating a new start in long-term thinking about boosting the drug industry, squeezes the thinnest and weakest […]
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Desperate Measures: Industry Teams with Parallel Traders to Tackle Counterfeiters in Europe

While action is heating up at the international level to tackle counterfeit drugs, Europe is making its own efforts to stop fake medicines from entering the legal supply chain. An improbable cross-sector partnership is struggling to secure support for a pan-European system to keep counterfeits out. It’s improbable because it brings together not only manufacturers, […]
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