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Biosimilars Law in Limbo: An Update On Biosimilars and Politics

By Brian R. Dorn, Ph.D., JD of Merchant & Gould

Brian R. Dorn, Ph.D. is a patent attorney with Merchant & Gould in Minneapolis. He focuses his practice on biotech, pharmaceuticals, nanobiotech, and at the convergence of biopharma and medtech. He may be reached at

On March 23, 2010, the Biologics Price Competition and Innovation Act (BPCIA) was signed into law as part of the larger healthcare reform bill, the Patient Protection and Affordable Care Act (PPACA) of 2010. The BPCIA is designed to create an approval pathway for biological products that are demonstrated to be highly similar to FDA-approved biological products. Although the biosimilars law was enacted, it is not a settled matter. The political debate between supporters and opponents is still ongoing regarding many aspects of the PPACA. In fact, opponents are attempting to block the law's implementation via various means. The politics are relevant since the BPCIA could be subsumed into the political battle over the PPACA as a whole. This paper will address the potential effects of different legal and legislative scenarios and discuss whether the biosimilars law could change.


The PPACA has been challenged in court and will be reviewed by the United States Supreme Court. Although it is beyond the scope of this paper to analyze the constitutional issues, court challenges may apply to the biosimilars law since the PPACA lacks a sever...

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