Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether patent litigation could deter drug makers from developing biosimilars.
With so much litigation surrounding biosimilars, are companies hesitant to enter the space?
I don’t think that litigation is going to deter companies from entering the biosimilar space. There’s much more litigation in the small-molecule space via Hatch-Waxman regarding Abbreviated New Drug Applications, or ANDAs, than there is with biosimilars, and it’s never deterred companies from developing generics. In fact, according to the FDA, in 2016 there were 159 more ANDA approvals than in 2015, and 242 more ANDA approvals in 2014.
I think there will be companies hesitant to enter the space is the resource commitment necessary to develop a biosimilar and not so much because of the litigation. Unlike a generic small molecule, biosimilars require some clinical trials, and if they want interchangeable status, they’ll also likely need a robust switching study. That, along with the unpredictability in developing biologics and the necessity for significant facilities in terms of eliminating contamination and working with live cells, makes entering the space a daunting first step.
Now that said, biologics tend to be blockbuster drugs, and so far we haven’t seen a significant discount with respect to biosimilar pricing. So biosimilars have the potential to generate similar margins as innovator biologics without some of the upfront costs of development.
The other issue may be the fact that biologics tend to have many more patents than small-molecule products. So just as a matter of sheer volume, you’re going to see more patent challenges developing in the biologics space over time, in particular at the Patent Trial and Appeal Board, or the PTAB, at the USPTO via the post grant review and Inter partes review process.
But, I suspect many companies also see the importance and potential of being in biosimilars, particularly if there’s a clear path to interchangeable status. And one thing you can always count on in science is that someone will have the passion and vision to pursue this.