Biotech Values

[genisi]

There are many complicating factors with Copaxone that I don't think a generic can be proved identical in the way small molecule generics do. Its complexed formulation - a mixture of synthetic polypeptides containing random sequences (of 4 amino acids) of varying lengths and ratios, makes showing that you have the identical mix in the soup not good enough. You also need to show that the composition of your product is the same because it may vary depending on how it is formulated and polymerized. Attempting to replicate such random formulation might result in hight variability and with the current FDA environment it is very likely they will require clinical work and perhaps specific requirements such as switching studies,imho.