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Biosimilars require more robust analytical data

At Biosimilar Drug Development conference recently held in London, Mark McCamish / Head Global Biopharmaceutical Development at Sandoz presented latest trends of the ever changing regulatory framework for ...

Cipla launches Enbrel biosimilar in India

Cipla has launched the first biosimilar of Pfizer and Amgen's rheumatic disorder blockbuster Enbrel in India. The company will sell its version of Enbrel (etanercept) under the brand name Etacept which will be ...

EMA To Accept Non-EU…

EMA To Accept Non-EU Or Non-EEA Reference Medicinal Product RMP For Biosimilar MAAs. European Biosimilars developers will be glad to hear that the reference product of the Originators biologic, can be ...

New EU GDP Guidelines

We are all anxiously waiting for the final version of the new EU GDP Guidelines that are expected for release early 2013. We attended a seminar end of November in Munich to hear the latest news from the Head ...
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