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.
You may also be interested in...
Months after obtaining the first US FDA designation of interchangeability, for its Semglee biosimilar to Sanofi’s Lantus, Viatris has seen a return on its investment, with the biosimilar scooping preferred status on one of the largest national formularies in the US.
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.