Replies to post #180694 on Biotech Values

[DewDiligence]

Re: 351(k) “patent dance”

Now that NVS has had its 351(k) submission for a Neupogen FoB accepted by the FDA for review, how do the two companies (NVS and AMGN) resolve the patent issues? Here’s a discussion of the process (from @biosimilarz):

http://www.biosimilarz.com/?p=587

At first glance, what the blogger calls the patent dance seems hopelessly complicated; however, the primary CoM patent on the reference drug will almost always have expired by the time the FoB company gets to this stage of development, which eliminates one major source of contention.

[DewDiligence]

FDA advisory panel for NVS’ Neupogen FoB scheduled for 1/7/15:

http://www.mmm-online.com/fda-plans-review-of-sandozs-neupogen-biosimilar/article/387688/

This will be the FDA’s first-ever advisory panel for a submission under the 351(k) regulatory pathway.