The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
US Enbrel biosimilar could be available as early as February 2017
Biosimilar labeling will have to include a statement describing the product’s relationship to its reference drug, according to US FDA draft guidance published yesterday.
FDA’s Janet Woodcook has defended delays in producing biosimilar interchangeability and labelling guidances, saying the scientific framework must first be ‘bulletproof.’
Sandoz has joined biosimilar developers calling on the US FDA to provide clear guidance on interchangability just a day after launching Zarxio, its Neupogen (filgrastim) copycat.
If each biosimilar to a reference product doesn’t get a different HCPCS (Healthcare Common Procedure Coding System) code, providers “may not be confident that they they will receive appropriate payment,” Juliana Reed, President of the Biosimilars Forum,...
With the release of three final guidance documents on biosimilars, the FDA is offering more clarity for developers seeking to fine-tune their understanding of the science and quality of biosimilars.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
