A key component of the Patient Protection and Affordable Care Act (PPACA) of 2010 has just been released with little fanfare. One of the most significant provisions in the law gives the Food and Drug Administration (FDA) the authority to regulate biosimilars, which are attempts to replicate some of the most complex medicines known as biologics. These advanced medicines treat serious medical conditions including cancer, multiple sclerosis, and rheumatoid arthritis. Last week, the FDA provided draft guidance that will eventually lead to the introduction of biosimilars in the U.S.
To date, there are no biosimilars in the U.S. market because they were considered “too complex” to include in the 1984 Hatch-Waxman legislation, which regulates the generic drug industry in America. In recent years the European Union, Canada and several other jurisdictions have made biosimilar versions of biologic products available for sale, and the United States is currently following suit.