On December 19, 2018, Ha Kung Wong was quoted by the Center for Biosimilars on a ruling by a federal judge in the Federal District Court in Fort Worth (Texas v. Azar) that the Affordable Care Act (ACA)'s individual coverage mandate is unconstitutional, noting that the rest of the ACA cannot stand in the absence of the individual mandate.
According to the article, the biosimilars industry is concerned about the future Biologics Price Competition and Innovation Act (BPCIA), which provides the basis for the biosimilar regulatory pathway in the United States. The BPCIA was passed as part of the ACA, and provides the framework under which biosimilars and interchangeable biologics can be approved by the FDA, which could now be at risk if the Supreme Court agrees with the federal judge's ruling.
Mr. Wong said, "If the [ACA] is actually found to be unconstitutional in its entirety after the eventual appeal, the BPCIA biosimilars pathway would essentially cease to exist and need to be passed by Congress all over again."
Mr. Wong added, "Although Republican governors and state attorneys general brought the Texas case and support the unconstitutionality of the ACA, there has been no indication that that they want to replace the biosimilars pathway portion of the ACA. With that said, we’ve had years of concerns, ambiguities, and issues with respect to the biosimilars pathway, and if it were up to be passed by Congress again, there certainly would be significant discussion from stakeholders whether aspects should be changed the second time around, such as the current optional nature of the process post-Amgen v Sandoz."