AAM files amicus brief supporting biosimilars pathway

The Association for Accessible Medicines has filed an amicus brief in the latest constitutional challenge to the Affordable Care Act, arguing that even if the individual mandate of the ACA is deemed unconstitutional, the biosimilars pathway or BPCIA should survive.

“FDA-approved biosimilars offer patients and taxpayers enormous cost savings on life-saving treatments,” said AAM interim CEO and general counsel Jeff Francer.

Francer said that AAM and its members supported the strong bipartisan consensus that led to the passage of the Biologics Price Competition and Innovation Act of 2009, and "we are proud to continue to support this regulatory pathway. If a constitutional challenge to some provisions of the ACA resulted in the invalidation of the entire ACA, including the BPCIA, a decade of progress by AAM and its members would be lost — and at a crucial moment.”