Imron Aly, JD: Settlements Over Humira

Imron Aly, JD, partner at Schiff Hardin LLP, explains how European cases influenced US patent litigation over Humira.


Why will US patients have to wait longer for biosimilar adalimumab than EU patients?

The Humira question is really an interesting one. In Europe the patent litigations had already been underway, whereas in the US, they were trailing a little bit behind. So once the first filer for any biosimilar product settled in Europe—setting the dates and everything that went with that—it made it harder for others to challenge it in the US and be incentivized to continue litigation when there was a sure bet and a sure launch date coming up that probably couldn’t have been beaten anyways with a long, drawn-out fight.