Biosimilars Pathway Enacted
March 24, 2010
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.
Click here to view a full summary of the key provisions in the Patient Protection and Affordable Care Act (H.R. 3590) related to the development of biosimilars.