The FDA needs to step up and fix the definition of strength. "Business as usual” under the existing language of the Biologics Price Competition and Innovation Act of 2009 means continued disincentives to promote a more aggressive uptake of biosimilars.
CRISPR-Cas9, unlike other methods, can create food products so close to the original that they are not considered genetically-modified organisms. That's because it's not how the process of change is of regulatory concern, but instead, it's the final result. Biosimilar is not genetically modified.
Biosimilars are less expensive generic versions of expensive biologic medicines. Rheumatologists, who prescribe a lot of these medications, have a few concerns about how they're approved. Namely, if these meds provide identical treatment as biologics, and that they're expensive. A position paper and accompanying editorial have been written focusing on these issues.
The big question about biosimilars is, is similar good enough?
A big story today is that the FDA, for the first time, has approved a so-called biosimilar drug. The thrust of the news is mostly regulatory and economic:
As reported in today s Wall Street Journal, an FDA advisory panel has voted unanimously to recommend the approval of a new product from Novartis called Zarxio. Assuming that the FDA follows the panel s advice (they usually do), a bit of pharmaceutical history will be made the ability of companies to develop and market biologic drugs that are similar to those of other companies.