Liability: The big biosim legal scuffle the industry should be anticipating
The FDA made history when it approved Novartis/Sandoz's Zarxio, the first-ever biosimilar drug to be cleared for the U.S. market, in March of 2015.
But the agency was late to the game. Dozens of other nations already had biosimilars jostling against branded biologics by the time Zarxio's approval came around. And U.S. regulatory agencies have felt the wrath of manufacturers eager to claim their stakes in a lucrative market which has largely been alien to U.S. consumers and the healthcare system until recently.
As we've previously reported, there are a number of critical questions surrounding the future of biosimilars in the U.S. Many of those questions, centering on biosimilar pathways, naming conventions, and other issues, will have to be addressed in the coming year(s).
But attorneys from top U.S. law firm Goodwin Procter explained to BioPharma Dive that there's one issue in particular that firms will have to pay heed to in the coming months and years: liability.
The difference between biologics and generics
"A lot of folks have thought of biosimilars as generic biologics," said Robert Cerwinski, a partner in Goodwin Procter's IP litigation arm, in an interview with BioPharma Dive last month. "That there would be the same cost savings, same abbreviated pathways, all of that.
"For small molecule generic drugs, there haven't been a lot of product liability lawsuits that have succeeded. And that's because of certain requirements by the FDA for copying the label and for having to adhere to the same chemical structure of the active ingredient that have shielded generic manufacturers from 'failure to warn' kind of liability, and design liability."
A different legal game for biosims
But that shield won't necessarily hold up when it comes to biosimilars.
"[W]ith biomsimilars, the product is not the same. It's similar, but not the same. And it's entirely unclear how much of the label the biosimilar is going to be permitted to copy, [unlike with other generics]. There's no statutory or regulatory provision that requires them to copy the label as there are with generic drugs."
The impact of this fundamental difference, and the questions surrounding what regulators' and the courts' approach to this difference might be, should weigh heavily on the industry's mind, according to Cerwinski.
"Are biosimilars going to be exposed to a higher degree of risk of product liability lawsuits than generic drugs? And how does that weigh into the overall economics of biosimilars?" he asked. "And it's not being talked about right now, because a lot of people don't know what the labeling requirements are ultimately going to be.
"But it's something people should be thinking about."
Stay tuned for more analysis on the issues which will surround biosimilar development in the near future, including further insights from Goodwin Procter experts.