Biotech Values

[DewDiligence]

Re: FoB's

The salient point apropos to drbio’s post is that the recently enacted law (and the FDA regs it will spawn) is good news for such companies as MNTA and TEVA. These companies lobbied Congress to have the law written the way it ended up being written, giving the FDA discretion over whether to require clinical trials for a given biosimilar/biogeneric. Additionally, the companies were successful in getting the law to allow substitutable biogenerics at the FDA’s discretion.

The companies’ lobbying was not successful in reducing the 12-year period of data exclusivity for branded biologics, but the duration of data exclusivity is much less consequential than the provisions giving the FDA discretion over the requirement for clinical trials and allowing substitutable biogenerics.