Replies to post #8677 on Momenta Pharmaceuticals, Inc. (MNTA)

[Goo111]

Read the slide about the transition to 351. In the cases where products are redefined, the FDA needs to stipulate which regulatory framework to follow.

I think you are underestimating the amount of change that will happen from the new biologics pathway... the very terms with which you speak are being redefined. The pathway will affect products that were previously not considered biologics, which ones I do not know.

[Goo111]

<<I do not understand what you mean. If generic Copaxone is approved under 505(j), why would it need to be “transitioned”? <<

Don't ask me... ask the FDA...

"As of March 23, 2020, an application for a biological product approved under section 505 of the FD&C Act will be deemed a biologics license application (“BLA”) licensed under section 351 of the PHS Act."