Biotech Values

[Biowatch]

Re: MNTA and CP delays for ANDAs

Is there a "typical" length of time that filing Citizen Petitions works in slowing down the approval process for generic drugs?

Is there even a ballpark figure / best guess estimate for a small protein product? (Or larger proteins.)

In a general way, how will it affect "follow on" biologics that involve a highly characterized (in terms of glycosylation) small protein such as Copaxone?

How well do boilerplate CPs work if a particular company wants a generic drug approved (or not)?

How does the increase in generic drug applications versus the flat staffing levels in OGD factor into the equation?

Disclaimer: I used to own NSTK (now MRNA), and their Calcitonin ANDA is still in CP / approval limbo/purgatory. Fans of the stock assume the FDA is at fault. Cynics might think otherwise. Hard to tell from the outside.

However, the money spent to have a lawyer file a CP that delays an ANDA approval is pennies on the dollars lost by having generic competition on the market.