The European Medicines Agency (EMA) announced on 27 January 2017 that Sandoz had withdrawn the marketing application for its pegfilgrastim biosimilar (Zioxtenzo), after the agency expressed doubts about its biosimilarity and manufacturing.
Sandoz officially notified EMA on 18 January 2017 that it was withdrawing its application for Zioxtenzo. The biosimilar was intended to be a biosimilar of Amgen’s Neulasta (pegfilgrastim), which is used in cancer patients to treat neutropenia.
Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue filgrastim. It serves to stimulate the level of white blood cells (neutrophils). Pegfilgrastim treatment can be used to stimulate bone marrow to produce more neutrophils (white blood cells) to fight infection in patients undergoing chemotherapy.
Sandoz withdrew its application after the EMA’s Committee for Medicinal Products for Human Use (CHMP) had evaluated the initial documentation provided by the company and formulated a list of questions.
In its list of questions, the CHMP had raised two main concerns:
- Study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta.
- Lack of a certificate of Good Manufacturing Practice (GMP) for the medicine’s manufacturing site. An inspection of the site will therefore be needed before the medicine can be approved.
The committee was therefore ‘of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta’.
The company had not yet responded to the questions at the time of the withdrawal and had therefore ‘not demonstrated that Zioxtenzo is highly similar to Neulasta and an inspection to confirm that it was being manufactured according to GMP standards had not yet taken place’.
It is not known where the biosimilar was being manufactured and why the facility was not approved by EMA. However, Sandoz told EMA that ‘it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure’.
Sandoz also received a rejection, in the form of a complete response letter, for its pegfilgrastim biosimilar (LA- EP2006) from the US Food and Drug Administration in July 2016 [1].
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 3]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application
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