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, he made clear that the interchangeability drive with the U.S. wasn’t just about the U.S. helping the U.K. – it’s a two-way street, he said.

Interchangeability is important for a variety of reasons, particularly with regard to biosimilar drug acceptance and the ability for the interchangeable biosimilar to be substituted for a ...

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.

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 ...

As more biosimilars are approved by the FDA, and with more in the development pipeline, the issue of interchangeability is raising red flags and causing concern among physicians about the future ...

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 interchangeability could raise a lot of confusion on why starchy vegetables are important to a diet and why different foods are recommended, Johnson said. Additionally, ...

Experts reflect on interchangeability between oral and intravenous therapy in patients with higher-risk myelodysplastic syndromes. News. All News Press Releases Product Approvals and Launches.

While the desire is interchangeability, there will only be interchangeability within specified pressure ranges. Low-pressure systems will still require low-pressure cylinders and 4,500-psi systems ...