Replies to post #95276 on Biotech Values

[DewDiligence]

can you explain how the regulatory pathway for biogenerics helps? I think the new regulations hurt companies pursuing bio generics. The fda is asking for safety and efficacy studies.

The new regs do not unconditionally require clinical trials for FDA approval of biosimilars/biogenerics; rather, they give the FDA the authority to determine on a case by case basis whether clinical trials are warranted—see #msg-48581353.