I saw a couple articles this week on the topic of how the FDA will handle review of biosimilars applications without revealing either the innovator's or the biosimilars applicant's trade secrets. I don't suppose anyone considered this complex issue during passage of the Biologics Price Competition and Innovation Act (BPCIA). How could they have? It probably took months to come up with the Act's name.
The possible revelation of trade secrets apears to be a real issue now that the hard work of implementing the Act is underway. There seem to be a real prospect that the FDA will indeed overtly or inadvertently get drawn into the act of divulging company secrets -- in many instances through no fault of its own.
The prospects are most likely in revealing trade secrets around manufacturing processes. The liklihood is enhanced as the FDA almost certainly must review these processes as a key part of determining the similarity of a an applicant to a reference drug. In fact, many biosimilar applicants try to determine these processes so they can mimic them and hopefully enhance their chances of matching the original licensed product.
The FDA reveiw process might reveal trades secrets of either the originator or the applicant in several ways:
(which you'll have to continue on Bruce Lehr's Big Red Biotech's post to do it justice)
http://thebigredbiotechblog.typepad.com/the-big-red-biotech-blog/2012/10/trade-secrets-a-biosimilars-complication.html
The possible revelation of trade secrets apears to be a real issue now that the hard work of implementing the Act is underway. There seem to be a real prospect that the FDA will indeed overtly or inadvertently get drawn into the act of divulging company secrets -- in many instances through no fault of its own.
The prospects are most likely in revealing trade secrets around manufacturing processes. The liklihood is enhanced as the FDA almost certainly must review these processes as a key part of determining the similarity of a an applicant to a reference drug. In fact, many biosimilar applicants try to determine these processes so they can mimic them and hopefully enhance their chances of matching the original licensed product.
The FDA reveiw process might reveal trades secrets of either the originator or the applicant in several ways:
(which you'll have to continue on Bruce Lehr's Big Red Biotech's post to do it justice)
http://thebigredbiotechblog.typepad.com/the-big-red-biotech-blog/2012/10/trade-secrets-a-biosimilars-complication.html
No comments:
Post a Comment