Biosimilars: the Big Picture
In the midst of wrangles over biosimilars naming and interchangeability, let’s not forget the key benefit – putting the brakes on the growth in biologics expenditure.
Joshua Cohen |
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 essentially does for large-molecule biosimilars what the 1984 Hatch–Waxman Act did for small-molecule generics, and the regulatory pathway is widely expected to speed the development and marketing of biosimilars in the US (1). In March 2015, the FDA approved Zarxio (biosimilar filgrastim), which is the first product to successfully complete the new regulatory pathway.
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