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The hurdles to biosimilars in Europe Biosimilars/General | Posted 19/11/2010

The stage is set for the entrance of biosimilars into the healthcare market. Patents are near expiry on the first biopharmaceuticals and the global biosimilars market is predicted to be worth more...

Go Perrigo! Generics/News | Posted 19/11/2010

Generic drug maker Perrigo has made it to Fortune magazine's top 100 fastest growing companies in the US. Fortune is a business magazine especially known for ranking companies by revenue. So there...

Bristol-Myers Squibb looking stronger than expected Pharma News | Posted 19/11/2010

Plavix (clopidogrel bisulfate), which prevents blood clots in patients at risk of heart attack or stroke and is the world's second biggest-selling prescription drug, loses US patent protection in N...

Biosimilar EPOs show the same or better quality Biosimilars/Research | Posted 12/11/2010

Researchers have found biosimilar erythropoietin (EPO) products have the same or even better quality compared with the original branded products.

FDA user fees for assessing generic drugs Generics/News | Posted 12/11/2010

The FDA is beginning a long-awaited attempt to create a system of user fees for assessing generic drugs. The US agency has a backlog of more than 2,000 products to review and has been short of fund...

EU patents limp forward Policies & Legislation | Posted 12/11/2010

The Belgian EU Presidency is trying to break the deadlock over proposals for a single EU-wide patent system, which has been blocked for over a decade due to language issues.

US guidelines for biosimilars Guidelines | Posted 12/11/2010

Last update: 25 October 2019The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Hurdles to biosimilars in Asia Biosimilars/General | Posted 12/11/2010

Now that a clear regulatory pathway for marketing biosimilars has been established in Europe, will Asian companies enter the global biosimilars race? Asian manufacturers face the same obstacles as...