Although the FDA has offered a pathway for the interchangeable designation, a recent presentation at the AMCP Nexus meeting shone a new light on some fairly important challenges posed by the interchangeable designation. Edward Li, PharmD, MPH, Professor of Pharmacy, University of New England, Portland, Maine, raised the well-trod issue of manufacturing drift—that over time, the … Continue reading Interchangeability: Another Challenging Perspective
Tag: manufacturers
Accounting for Lot-to-Lot Variability of Biologics in Biosimilar Development
The biosimilar manufacturer must obtain “a minimum of 10 reference product lots” and these lots “should represent the variability of the reference product,” against which the biosimilar drug is evaluated to allow for meaningful comparisons. In other words, the biosimilar manufacturer must consider the likelihood of variation in the local source of the biologic.
Is There Reason for Confidence in Big Pharma for Biosimilar Manufacturing?
A payer market research project we conducted not long after the passage of the Biologics Price Competition and Innovation Act posed the question: What are the characteristics of the biosimilar manufacturer that would give you confidence in the product’s integrity and supply?
Can Biosimilars Be Protected By Patent?
“Are biosimilars patentable?” Sounds like a simple question, right? Well, the answer may not be straightforward, and relate to another question: "Exactly how different are they?"