Sandoz announced that its biosimilar application for Neulasta® (pegfilgrastim) has been accepted for regulatory review by the European Medicines Agency (“EMA”). According to Sandoz, “[t]he comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.”
Sandoz previously withdrew its application for pegfilgrastim from the EMA. In its withdrawal letter, Sandoz indicated that it “will not be able to provide the additional information required by the CHMP [Committee for Medicinal Products for Human Use] within the regulatory timeframe for this procedure.” However, Sandoz also stated that it “intends to resubmit the application as soon as the outstanding information is available.”
The EMA had two main concerns with Sandoz’s prior application. First, was that “study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo [Sandoz’s proposed biosimilar] and Neulasta.” Second, the EMA objected to “the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine’s manufacturing site.” The EMA further noted that at the time of the withdrawal Sandoz had not demonstrated that its proposed biosimilar was highly similar to Neulasta® and an inspection of the manufacturing facility had not yet occurred.
We will continue to keep you updated on further developments.