Joel Wallace was quoted on a recent ruling from Federal Judge Reed O’Connor in the Federal District Court in Fort Worth, Texas, that the Affordable Care Act’s (ACA) individual coverage mandate is unconstitutional and, in the absence of the individual mandate, the rest of the ACA cannot stand.
Joel said that since the Biologics Price Competition and Innovation Act (BPCIA), which provides the basis for the U.S. biosimilar regulatory pathway, was passed as part of the ACA, the ruling could have significant consequences.
“First, the ruling could undo the entire U.S. biosimilars industry, because without the ACA, there is no statutory framework for biosimilar drug approval,” he said. “Second, Judge O’Connor’s opinion could potentially leave millions of patients without prescription drug insurance coverage, hurting both the patients themselves as well as the pharmaceutical industry’s bottom line.”
However, Joel added that since no injunction has yet been issued related to the ACA, U.S. biosimilars companies should continue with business as usual. But all biosimilars manufacturers should keep a close watch on the litigation, as it has the potential to significantly impact business in the days ahead.
Read the full article here.
Read more about the potential impact of the ruling on the U.S. biosimilars industry here.