FDA Law Blog: Biosimilars

JULY 11, 2023

To set the stage for this case, we need to go back to March 2020 , when a new definition of “biological product” threw the world of protein products into a tizzy. FDA further defined the term “protein” so that it includes any peptide product that has an amino acid sequence greater than 40 amino acids.

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FDA Regulations Production Small Molecule 95

FDA Law Blog: Biosimilars

MARCH 5, 2024

Gaulkin & Riëtte van Laack — As readers of this blog know, there is a lot of contention about the naming of alternative protein products (APPs), including both plant-based and cell-cultured alternatives for (traditional) animal products. By Sophia R. This particular federal legislative effort, however, continues the debate.

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Protein Production Production DNA Regulations 59

Agency IQ

APRIL 12, 2024

Cell-based assays , while more complex to develop and use, offer another option for characterizing product activity at a slightly higher level, allowing sponsors to measure the further downstream effects of products (e.g., morphological cell changes or alterations in protein production or expression).

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Production FDA Therapies Biochemical Assays 40