Regulation, Policy, and Litigation in Biosimilars - Episode 5
Amanda Forys, MSPH: The FDA and EMA [European Medicines Agency] have signaled a need for greater regulatory alignment in terms of sharing inspection information, and the agencies have entered a new agreement to share full inspection reports with one another. How has the industry received news of this change in the types of information being shared among regulatory bodies?
Ha Kung Wong, JD: My impression, from at least people that I work with, from the intellectual property (IP) side is that there is some concern about the fact that confidential information can be included in these types of reports. And they are, often, because a lot of this is manufacturing information. In the United States, obviously trade secrets are very important to manufacturing. A lot of those things can be included in these inspection reports. Typically, the FDA has been sharing redacted reports to take out the trade secrets. But with this type of cooperation, which is good, you want to have cooperation and want to make sure resource management is done correctly. But you always run the risk of disclosing those trade secrets.
As anybody who’s worked with trade secrets knows, once it’s out there, it’s out there. You’re not getting it back. KFC’s secret recipe of 11 herbs and spices—when it’s out there, it’s gone, right? You’re not going to be able to recover that. The more times it’s duplicated, the more times it’s sent out. You send it out to a regulatory agency in Europe and they say, in their press release, “This agreement recognizes that Europe has the authority and demonstrated ability to protect confidential information.” Well, that leaves industry in the position of crossing their fingers and hoping that’s true. It’s a little bit scary, from an IP perspective.
Amanda Forys, MSPH: Do you think that this type of relationship is a wise use of resources? Or, do you think this is something that could potentially delay approval and subsequent availability of biosimilars?
Molly Burich, MS: I think it’s to be determined, in a lot of ways, because it’s a relatively new development. But, I do think that the timelines, often, are different between approval in different countries. So, that’s built in to the process already. I think the bigger question is, how much are the agencies going to be able to keep what should be proprietary, proprietary?
Ha Kung Wong, JD: Yes. Since 2012, the FDA has had authority to actually share the trade secret information to European regulators, but they haven’t. They’ve actually only given redacted reports. So, it goes to show that the FDA does understand the importance of this—to, particularly, biologics. A lot of times, that’s the really important aspect of making your product.