FDA Process

Biologics are not covered under the 1984 Hatch-Waxman Act, which created an abbreviated approval process for generic versions of conventional drugs. On March 23rd, 2010, however, President Obama signed into law the Patient Protection and Affordable Care Act that included a pathway for the approval of biosimilars (also referred to as the Biologics Price Competition and Innovation Act (BPCIA)). This abbreviated approval pathway for biosimilars gives the FDA authority to define the implementation process. The law also gives the FDA the authority to further define the detail regarding scientific standards and the extent of analytical, preclinical and clinical data necessary for the approval biosimilars to ensure patient safety and the effectiveness of the biosimilar. Read more at the FDA’s website.