Tentative Biosimilar Approvals Under Consideration By FDA
US Agency Is Actively Considering Applying Generic Concept To Biosimilars
Concept could help sponsors who reach approvability but must wait several years before reference product exclusivity expires.
You may also be interested in...
Biosimilar sponsors want meeting and assessment best practices implemented across divisions, but the FDA says that may be difficult and time-consuming.
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.