Patient Protection and Affordable Care Act (H.R. 3590)—Approval Pathway for Biosimilar Biological Products


On December 24, 2009, the U.S. Senate passed the Patient Protection and Affordable Care Act (H.R. 3590), its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives also passed this legislation. Included therein is a provision (Section7002) amending the Public Health Service Act to permit approval of biosimilar biological products through an abbreviated biological license application (ABLA) submitted to the Food and Drug Administration (FDA).

The House additionally passed a reconciliation bill (currently pending in the Senate) meant to alter several provisions of H.R. 3590, however, no provision affecting biosimilars was included. H.R. 3590 was signed by the President and enacted into law on March 23, 2010.

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