The nation’s highest court today ruled critical parts of the Patient Protection and Affordable Care Act (PPACA) constitutional, and with it the Biologics Price Competition and Innovation Act (BPCIA) giving the FDA authority to approve biosimilars.
Had the PPACA been stricken in part or in its entirety, it would have presented obstacles to the BPCIA surviving in its present form. In particular, the US government has been critical of the 12-year data exclusivity period for innovators, calling for it to be shortened to seven years.
“We’ve avoided a protracted fight over new legislation in this area,” said Gerald Flattmann of Paul Hastings. “There could have been a multiyear delay in biosimilar approval.”
This was the best case scenario for the biologics industry, which feared that even had the BPCIA stayed intact while other provisions were deemed unconstitutional, it would have been difficult for it to have survived.
Still in question, however, is what the regulatory framework will ultimately look like.
“The FDA has provided very few tangibles or nuts and bolts considering what the approval process is going to look like and whether it will be much less onerous than the approval process already in place for innovator biologics,” Flattmann said.
But, he added: “We’re in better shape than we would have been had this portion of the law been stricken.”
