Sandoz received a complete response letter from the US Food and Drug Administration (FDA) in regard to its pegfilgrastim biosimilar application, filed in 2015.
As reported in July, Sandoz received a complete response letter from the US Food and Drug Administration (FDA) in regard to its pegfilgrastim biosimilar application, filed in 2015. On its third-quarter earnings call, Novartis provided further hints at the reason for FDA’s rejection of this biosimilar. Apparently, further data are required.
Novartis’ Sandoz unit has several additional biosimilar assets, including its marketed filgrastim-sndz product Zarxio, its recently approved biosimilar to Enbrel, and its investigational infliximab biosimilar (purchased from Pfizer after that company’s acquisition of Hospira).
Vasant Narasimhan, MD, Novartis’ Global Head of Drug Development and Chief Medical Officer, confirmed, “As noted in the second quarter, we did receive a complete response letter and are continuing to engage in discussions with those at FDA and with EMA. In the US, we have agreed with the FDA to move forward on an additional study to address their data request. We would expect to submit that study to the FDA in 2018.”
In other news… The biosimilar partnership between Momenta Pharmaceuticals and Mylan took another step recently, when they announced the commencement of its phase 1 study of M834, a biosimilar of abatacept (Orencia). This investigation, slated to end June 2017, will evaluate the pharmacokinetics, safety, and immunogenicity of this biosimilar in comparison with both the US and EU-licensed versions of Orencia in healthy volunteers. This is the first of 6 biosimilars in the Momenta—Mylan partnership to reach the clinical trial stage.