The US FDA expects biosimilar developers to provide data from switching studies to demonstrate interchangeability with a reference biologic in draft guidance published today.
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.
The FDA has finally released its biosimilar draft guidance for industry, which details how it will evaluate comparative analytical characterization of the biosimilar in relation to the reference product.
