Supreme Court Upholds Regulatory Pathway for Biosimilars Approval
June 28, 2012

Today the U.S. Supreme Court issued its long awaited decision regarding the constitutionality of the 2010 Patient Protection and Affordable Care Act (“ACA”). This Act provides a legal framework for regulatory approval of biosimilar drugs, among other things, which heightened the biopharma industry’s interest in the Court’s decision. For the most part, the Court upheld the constitutionality of the ACA, including the pathway for biosimilars approval. As a result, the Court’s decision may provide greater certainty to the industry and allow it to refocus on the economic feasibility of developing biosimilars under the abbreviated pathway.

If you have any questions or wish to discuss how the Court's decision may impact your company, please contact your attorney at Brinks Gilson & Lione, or one of our BioPharma attorneys.

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