Replies to post #8680 on Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

"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."

This passage clearly refers to branded drugs previously approved under Section 505. The intention is to allow 351(k) biosimilars of such previously approved branded drugs starting in 2020.

Your observations in this thread have no practical consequence whatsoever for MNTA's Copaxone program, but don't take my word for it. Call NVS or MNTA and ask.