Published Article

Recent Regulatory Developments in US Biosimilars Market

April 20, 2018


While the Biologics Price Competition and Innovation Act (BPCI) was originally enacted under the Obama Administration as part of the Affordable Care Act, it appears that the Trump Administration will continue to take steps to promote and foster the development of biosimilars as part of a larger policy effort to make drugs and biological products more affordable for patients. In particular, the Centers for Medicare & Medicaid Services (CMS) has established new payment and coding policies for biosimilars reimbursed by Medicare. More recently, the Bipartisan Budget Act of 2018 includes a provision to reduce patient cost sharing for biosimilars under the Medicare Part D Prescription Drug Benefit.

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