Can Biosimilars Compete With ‘Unbranded Biologics’ In The US Market?
Biologics with their brand name dropped from the label could become the alternative to an ‘authorized biosimilar,’ which is not allowed under the law.
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Rheumatologists may be more cautious about prescribing biosimilars to Humira than they have been for biosimilars to Avastin and Herceptin. But pharmacy benefit managers will have more influence over Humira biosimilars, which adds a new dynamic to the follow-on market.
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.