Biosimilars: Exclusivity Guidance Possible; Head-To-Head Comparison Studies Sinking In
FDA’s Denise Esposito says that in many cases the agency will require biosimilar sponsors to conduct head-to-head comparison studies with the reference product.
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The Office of Generic Drugs may evolve to focus more on clinical issues as the new Office of Pharmaceutical Quality creates uniform standards for manufacturing process engineering and other production areas, the CDER director says in an interview.
Developments in off-label enforcement and scrutiny of economic superiority claims, new approaches to R&D, and biosimilars are among issues that captured readers’ attention last year.
Generic Pharmaceutical Association, with research from IMS Health, says the savings to the U.S. health care system from using generic drugs were $1.07 trillion over the past 10 years, a figure the group believes should be taken into consideration when looking for solutions to the general fiscal crisis facing the U.S. The association is going to focus on improving generic utilization on state and local level.