Holzkirchen, Germany, July 22, 2015 – The US Court of Appeals for the Federal Circuit issued a ruling on July 21 that paves the way for Sandoz to launch Zarxio (filgrastim) after September 2, as the first US biosimilar.
The court, which ruled following an appeal hearing on June 3, found that provision of the biosimilar application to the originator company within 20 days of filing – the so-called “patent dance” component of the US biosimilar approval pathway, or BPCIA — is optional.
However, it also ruled that the required notice of commercial marketing can …