It is important to note that interchangeability for either of these biosimilars would represent a tweak on a preexisting product. Abrilada was approved as a biosimilar by the FDA in 2019, and ...

U.S., U.K. Navies Working to Achieve ‘Interchangeability’ in Carrier Forces, Collaboration on Unmanned and AI Megan Eckstein October 20, 2020 10:43 AM - Updated: October 20, 2020 6:01 PM ...

Interchangeability, which is the standard for conventional, small molecule generic drugs, is challenging for biologic drugs because of their size and complexity, and because the biosimilarity ...

Basic components designed for single-use in bioprocessing aren’t as interchangeable as biomanufacturers often assume.

Even if there aren’t data, because interchangeability is an FDA approval, we just got our first biosimilar with that, hallelujah. But we’ve been using interchangeability differently through ...

"Interchangeability is the holy grail for the biosimilar market," said Parrish Galliher of GE Healthcare recently, at INTERPHEX. It's what will free biosimilar manufacturers from "any objections ...

Reclassification is a fairly black-and-white stance, while interchangeability indicates similarity between two food items, said a House Agriculture Committee staff member who discussed the issue ...

Interchangeability, in the biosimilar regulatory context, sets a higher bar than the test for biosimilarity, and it requires more data.” There are currently no FDA-approved biosimilars ...

Still, this falls short of the call for interchangeability, which might see American MH-60s embark on the Australian ship, while the two countries share maintainers and spare parts.

This interchangeability requirement is misguided on several levels, is counterproductive for the adoption of biosimilars, and will force Americans to pay billions of dollars more for these ...

The final interchangeability guidance is informed by the FDA's cumulative experience providing development-stage advice to sponsors of proposed interchangeable products.