Legal battles stall US biosimilars
Unclear legislation and lack of regulatory guidance means companies are turning to the courts
Since March 2015 and the first US approval of a biosimilar – Sandoz’s Zarxio, based on Amgen’s Neupogen (filgrastim) – another four follow-on biologics have received regulatory approval, with the fifth just last month. Yet only two of these products have actually hit the market, while eight US lawsuits are debating patent infringements and the interpretation of the relatively new Biologics Price Competition and Innovation Act (BPCIA). One case – Amgen versus Sandoz – has even reached the US Supreme Court, highlighting the legal quagmire that biosimilars find themselves in.