- US Supreme Court rules that six months’ notice of commercial marketing can be given prior to FDA approval in Sandoz vs. Amgen
- Justices also provided much needed clarity on the patent litigation process, often referred to as the ‘patent dance’
- As the first company to gain approval for and launch a biosimilar under the BPCIA’s new regulatory pathway, Sandoz continues to pioneer the path forward for these high-quality, cost-effective medicines in the US
Holzkirchen, 13 June 2017 – Sandoz, a Novartis division, today announced that the Supreme …