BsUFA Research Roadmap Highlights Interchangeability And Reducing Trials
US FDA Invites Feedback On Biosimilar Regulatory Science Pilot Program
The FDA has published a “Research Roadmap” setting out in detail its areas of interest for the agency’s biosimilar regulatory science pilot program under BsUFA III.
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Provisionally Interchangeable? FDA Weighs ‘Requirements’ For Pfizer’s Adalimumab
Pfizer has responded to Generics Bulletin’s queries regarding its bid to win an interchangeability designation for its Abrilada (adalimumab-afzb) biosimilar to AbbVie’s Humira reference product.
AAM Departures Lead To Change Of Chair For IGBA
The AAM has confirmed the departure of three executives, one of whom had also been serving as chair of the IGBA. As a result, the global generics industry association has brought in a new interim chair, at the same time as the head of one of the industry’s largest players has joined its CEO Advisory Committee.
Hitting A Moving Target: Teva’s Dethlefs Discusses US Complex Generics
With a number of US complex generic opportunities in Teva’s pipeline, the company’s executive vice president for North America commercial, Sven Dethlefs, talks about the challenges of bringing complex products to market against a backdrop of evolving FDA requirements.