MYL is merely the US regulatory and distribution arm for the Copaxone knockoff Natco sells in India. I don’t think this drug stands a chance of getting FDA approval as a generic version of Copaxone.
Hmmm. This sounds quite similar to another situation I can think of. ; )
Which do you give the better chance of receiving approval: Teva's generic Lovenox or MYL's generic Copaxone (let's make this apples-to-apples in some sense and assume that NVS/MNTA/MYL succeed on the Copaxone patent litigation)?
MYL is merely the US regulatory and distribution arm for the Copaxone knockoff Natco sells in India.
Anyone know of any trials of the branded drug vs the knockoff. It would provide an interesting assessment of how similar a drug has to be to glat to work.