Biosimilar Drugs – Approval and Process Appears Cloudy On the Biologic License Applications With HealthCare Reform Law and The New “Pathway”

With healthcare reform the purpose of the new pathway was to get drugs out to consumers faster, but in reading here it appears that some biotech companies are going to continue on with the same methods they have been using for the standard BLA application. Timing and patent expiration enter into the picture for sure here.

I’m sure we have not heard the last of this one either as there are longer times for the drug to be exclusive and as long as the options are there, it looks like some are staying with the original filing plan. The laws have been created and now how the FDA will interpret, well, this is maybe another complicated issue that has been tossed onto their already over flowing plate. To say the least, this is going to be an interesting watch to see how it works and how many pharmaceutical companies actually take advantage of the new “pathway” and if it is cost effective for them to do so.

Time will tell if we as consumers see the reality of less expensive drugs with biosimilars getting into the hands of our doctors any sooner. BD

But boy does it sound like an uphill climb from here. We were struck by the case made by Bob Dormer, a founding partner of the DC law firm Hyman Phelps & McNamara, who argues that--all things considered--sponsors are better off just filing a conventional BLA than bothering with the new "pathway" for biosimilars created by the health care reform law.
Dormer offered the following points:

You can file a BLA at any time (rather than waiting at least four years to file the new, abbreviated BLA--and at least 12 years total for the innovator's data exclusivity to expire before marketing is allowed).

A BLA filing is secret, preserving possible competitive advantages. An ABLA must be disclosed to the innovator.

You can get to court on patent issues quicker, without going through the cumbersome-looking administrative process set up for ABLAs.

The data requirements probably won't be very different--and, for the time being at least, the BLA requirements are more predictable.

Last but not least, you are entitled to 12 years of exclusivity on approval.
Dormer's not the only one who feels this way. As we noted in "The Pink Sheet," Novartis' Sandoz division says it will focus on the BLA route, given the drawbacks it perceives with the new pathway; Teva has also opted to file a BLA for one of its biosimilar projects, and says it may do the same in other cases while it waits and sees what FDA comes up with.
That may be the key point: how will FDA translate the legislation into a regulatory pathway? As the WLF panelists agreed, there are far more questions than answers at this point.