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, 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 ...

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 ...

Mistrust of bioequivalence has real clinical implications. With negative reports about the interchangeability of brand-name and generic drugs in the medical literature, popular media, and medical ...

Samsung Bioepis’ Hadlima, a biosimilar of blockbuster autoimmune diseases drug Humira, met primary endpoints in the interchangeability test, the Incheon-based pharmaceutical company said Wednesday.

Given the few interchangeability determinations to date, however, little can be said with any certainly about the agency’s broader thinking on these issues. FDA is seeking comments on the draft ...

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.

Singapore THE Currency Interchangeability Agreement between Singapore and Brunei, now in its 50th year, is testament to how cooperation between the two countries has deepened, as they both benefited ...