A Shift in Regulatory Thinking – Are Confirmatory Phase III Studies Redundant for Biosimilars?
In recent years biosimilar regulatory requirements across the world have converged and a broadly accepted......
24 September, 2018 No commentIn recent years biosimilar regulatory requirements across the world have converged and a broadly accepted......
24 September, 2018 No commentIntroduction Approximately $60 billion in US Humira sales will remain uncontested over the next four......
03 June, 2019 No commentIntroduction With over a decade of real world biosimilar experience in Europe and now more......
04 March, 2019 No commentThe NeuClone Biosimilar Brief is a biosimilar industry publication written by NeuClone exploring biosimilar related......
17 September, 2018 No commentIntroduction With 27 speakers and 78 follow-up electronic submissions, the Food and Drug Administration’s (FDA)......
04 October, 2018 No commentIntroduction Five biosimilar copies of the world’s highest selling drug, Humira (adalimumab), are about to......
12 October, 2018 No commentIntroduction With the recent announcement that NeuClone is developing a biosimilar candidate of Perjeta (pertuzumab),......
08 January, 2019 No commentIntroduction Approximately $60 billion in US Humira sales will remain uncontested over the next four years...
Introduction With over a decade of real world biosimilar experience in Europe and now more than...
Introduction With the recent announcement that NeuClone is developing a biosimilar candidate of Perjeta (pertuzumab), this...
Introduction Five biosimilar copies of the world’s highest selling drug, Humira (adalimumab), are about to launch...
Introduction With 27 speakers and 78 follow-up electronic submissions, the Food and Drug Administration’s (FDA) recent...
In recent years biosimilar regulatory requirements across the world have converged and a broadly accepted...
The NeuClone Biosimilar Brief is a biosimilar industry publication written by NeuClone exploring biosimilar related...