Biotech Values

[DewDiligence]

Re: Omnitrope approval and FDA's BS

To put it bluntly, the FDA’s contention that this is not a precedent-setting decision is BS, while NVS’ statement that the decision is precedent-setting is entirely justified.

The FDA’s argument for saying this is not precedent-setting is that the Agency has approved other protein drugs via Section 505; however, these prior approvals did not fall under via Section 505b2, specifically. This distinction makes all the difference in the world because a drug approved under Section 505b2—but not a drug merely approved under Section 505—may rely on the clinical data of the referenced branded drug (PFE’s Genotropin in this case) to demonstrate safety and efficacy.

Bottom line: the Omnitrope approval is good news for the companies who stand to benefit from generic biologics (NVS, TEVA, and possibly some smaller companies such as MNTA), and it is probably bad news for the likes of AMGN and DNA.