Biosimilars: Improving Patient Access To Biologics While Bending The Cost Curve

In 2010, the Affordable Care Act (ACA) established an abbreviated regulatory pathway for biosimilars. The pathway was based on regulations included in 2009 legislation on biosimilars: the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA has analogous objectives for large-molecule biosimilars as the 1984 Hatch-Waxman Act had with respect to small-molecule generics. The regulatory pathway is widely expected to speed the development and marketing of biosimilars in the US. In March 2015, the Food and Drug Administration approved Sandoz Inc.'s Zarxio (biosimilar filgrastim) – which is indicated to stimulate bone marrow growth – the first product to successfully complete the new regulatory pathway. Exhibit 1 lists biosimilars on the US market and those expected to be approved and launched in the near future.

Exhibit 1