Replies to post #54404 on Biotech Values

[DewDiligence]

>MNTA …the FDA contends that it may not be, or else why require immunogenicity studies.<

The FDA has not yet said they will require immunogenicity studies, although they may do that. All they’ve said so far is that they want more information vis-à-vis immunogenicity from all of the generic-Lovenox applicants (Teva, WPI/Amphastar, and Sandoz/MNTA).

[genisi]

"such analyses are very complex"

You can demonstrate that your drug is structurally highly homologous to another using high-resolution 3D structure, determined by X-ray crystallography.
Glycosylation can be analysed to determine the glycan structure and glycan quantitative ratio using sequential digestion with various exoglycosidases and HPLC, GC-MS, FAB-MS and DE-MALDITOF-MS and use HPAEC-PAD following digestion with trypsin and PNGase procedure to permits chromatographic comparison of oligosaccharide patterns in a qualitative and quantitative manner.
After doing all this, you can say that your drug is highly similar to the other. You still can never know if your drug will provoke an immune reaction.