Tags » INTERCHANGEABILITY
In terms of the biosimilar market and utilization, the US has been at least one full decade behind Europe in every respect but one. Yes, we have the EU beat in a game they avoided playing: The interchangeability gambit. 448 more words
Being “biosimilar” does not equal being “interchangeable.” As mentioned in yesterday’s blog post, the Food and Drug Administration (FDA) draft guidance… 543 more words
For decades, everybody has become familiar with many brand-name and generic chemically synthesized drugs that are small molecule drug products, such as amoxicillin, Lipitor, and Crestor. 567 more words
Clinical pharmacology studies are critical in demonstrating biosimilarity because they provide clinical pharmacokinetic/pharmacodynamic (PK/PD) similarity data to confirm biosimilarity. 407 more words
On January 10, the Food and Drug Administration (FDA) released its long-awaited draft guidance on the interchangeability standard for biosimilar manufacturing.
It’s been quite a while since we have been able to discuss progress on interchangeability, so as a reminder, the practical differentiator between a product designated as biosimilar versus interchangeable is that the latter “may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.” 182 more words