Sandoz withdraws Neulasta biosimilar application after EMA questions GMP status

By Dan Stanton

- Last updated on GMT

Image: iStock/serggn
Image: iStock/serggn

Related tags Food and drug administration

Sandoz withdrew its pegfilgrastim biosimilar application before responding to concerns about the lack of cGMP accreditation at the candidate’s manufacturing site, the EMA says.

Zioxtenzo (pegfilgrastim) – Sandoz’s potential biosimilar of Amgen’s Neulasta – was “withdrawn after the Committee for Medicinal Products for Human Use (CHMP) evaluated the initial documentation provided by the company and formulated a list of questions,”​ the European Medicines Agency (EMA) said last week.

But according to a letter received by the Agency​ on January 18, Sandoz said it “will not be able to provide the additional information required by the CHMP within the regulatory timeframe,”​ and as such withdrew its application.

Manufacturing concerns

The Agency had two concerns, one being that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta.

“The other concern was the 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.”

Sandoz has three sites dedicated to biosimilar production in its network – Kundl and Schaftenau in Austria, and Menges in Slovenia – and spokesman Chris Lewis confirmed to Biopharma-Reporter that its biosimilar manufacturing sites are all cGMP accredited.

The firm also has access to biopharmaceutical manufacturing capabilities across its parent company Novartis’ network, and has also previously told us​ it also uses third-party manufacturers for some of its biologics production.   

Lewis, when asked, would not provide further detail on Sandoz’s manufacturing plans for Zioxtenzo at this stage but said the firm “will take any necessary actions to continue to ensure GMP compliance.”

US rejection

The news comes as another blow for Sandoz’s pegfilgrastim candidate after being rejected by the US Food and Drug Administration (FDA) last July​.

However, according to Lewis, the reasons for the US rejection and the European withdrawal were not related.

“The FDA request was for additional data – and the requirements were not the same as for EMA.”

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