US Supreme Court agrees to hear Novartis' challenge of rule governing biosimilar launches

The US Supreme Court on Friday agreed to hear Novartis' appeal seeking to overturn a law that requires companies to wait 180 days after obtaining FDA approval for a biosimilar drug before they can begin marketing the product. In the case, Novartis, which was prevented from launching Zarxio (filgrastim-sndz), a biosimilar version of Amgen's neutropaenia drug Neupogen (filgrastim), until six months after the biosimilar was approved, has argued that the delay provides drugmakers with additional market exclusivity. "If not reversed, [the rule] will delay access by patients to all biosimilars for six months longer than Congress intended," the Swiss drugmaker stated. 

Opening arguments in the case are expected to be heard in April, with a decision expected by July. Celltrion, Mylan and Pfizer's Hospira unit were among the companies supporting Novartis' appeal. "Given the importance of the issue to consumers, taxpayers and competition in a vital new pharmaceutical industry, review is needed now," Celltrion and Hospira jointly stated. 

Meanwhile, the Supreme Court on Friday also agreed to hear Amgen's appeal regarding whether biosimilar manufacturers must provide the brand-name drugmaker with a copy of their application after it is submitted to the FDA. A US appeals court previously determined that such disclosures were not mandatory.