From Bloomberg Law :
But with the ACA surviving its latest Supreme Court challenge, Amin said “now is the chance” for lawmakers to resolve these issues and improve the biologics pathway. Congress may consider looking at more “standalone” options for biosimilar entry, given that the ACA is still prone to threats in the court system, said Charles Duan, senior fellow at the R Street Institute.
“There’s certainly a bit of risk” with having BPCIA tied up with Obamacare, Duan said. Lawmakers “may have some interest right now” for a standalone options so industry and patients “have clarity.”
- “Bloomberg Law”: https://news.bloomberglaw.com/pharma-and-life-sciences/obamacare-ruling-paves-way-for-fixing-flaws-in-biosimilar-system