资讯

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 ...
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.
"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 ...
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 assessments At a high level, interchangeability assessments include not only material composition but also the compatibility of assembly connections, shapes, validation ...
Pharma FDA's finalized biosim interchangeability rules should give copycats a boost: analyst By Angus Liu May 13, 2019 12:47pm biosimilar guidance insulin U.S. FDA ...
The interchangeability tag is expected to improve access for patients, physicians, payers and providers, Michael Goettler, Viatris’ CEO, said in a statement.