Supreme Court Hints Biosimilar Route Might Be Preserved


The survival of the biosimilars approval pathway seemed on surer footing today following oral arguments at the Supreme Court over the Affordable Care Act and the severability of its provisions.

The survival of the Affordable Care Act (ACA) without the individual mandate seemed a distinct possibility following oral arguments in the Supreme Court, and this bodes well for the survival of the Biologics Price Competition and Innovation Act (BPCIA), which is part of the ACA statute and enacts the pathway for biosimilar approvals.

“It’s hard for you to argue that Congress intended the entire Act to fall if the mandate was struck down,” Chief Justice John Roberts said. The individual mandate dictated that individuals must have health insurance or pay a penalty for not having it, although the penalty was abolished in 2019. The argument before the court is whether the ACA and its provisions can be salvaged without the mandate or if they must be struck down in their entirety.

Roberts said “there seems to be compelling evidence” that the intent of Congress was for the “rest of the law to survive if an unconstitutional provision were severed.”

The potential loss of the BPCIA was cause for concern in the biosimilars community, where the pathway has enabled 18 biosimilars to come to market so far, making lower-priced versions of costly biologics available to many patients and thereby expanding access to treatment. It is believed that a chaotic interruption to the development of the biosimilars market could erupt without the BPCIA and until Congress develops patch-up legislation as a replacement.

A decision on the case, California v Texas, is expected in the spring of 2021.

For more about the Supreme Court hearing, visit

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