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:
- The BLA package is public and contains key documents from the originator drug. There is even a prospect that other elements (like manufacturing processes) could be made public through FOIA filings.
- The FDA reviewers might inadvertently disclose innovator information to a biosimilar applicant during the review process.
- Biosimilar applicants must provide a copy of their application to the innovator within 20 days of notification of acceptance by the FDA possbily putting the former's trade secrets at risk.
- Biosimilar applicants must explain why they do not infringe the innovator's patents or why their patents are invalid. They may have to use their trade information to effectively make their case.
Thus, this new process has some possible bugs to be worked out. It remains to be seen whether the above issues will transpire or not. See Fierce Biotech.
Layer on top of this, Abbot's specific Citizen Petition filed with the FDA on the subject of biosimilars and trade secrets. Abbott has asked the agency to acknowledge that it will NOT make information from Abbott's Humira BLA available to any biosimilar applicant and in fact will not make information from any BLA filed prior to the BPCIA's passage on March 23, 2010 available.
Their argument? That by revealing its trade secrets, the FDA would violate the takings clause in the Fifth Amendment that requires just compensation -- and of course this information could be considered worth millions to billions.
On October 1st, the FDA responded to Abbott's citizen petition in writing (complying with the law to respond within 180 days of its receipt). The FDA said the agency "has been unable to reach a decision on Abbott's petition because it raises complex issues requiring extensive review and analysis by Agency officials." The FDA further stated it would respond to the petition as soon as it reaches a decision.
In other words, "We're caught between a rock and hard place and we don't know what the hell to do or say. Maybe if we don't say anything it will all go away like a bad dream." See Patent Doc blog.
Posted by Bruce Lehr Oct 25th 2012.