EMA raises manufacturing questions over Novartis biosimilar production

Novartis, which is investing $1 billion in biologics manufacturing, has been questioned by the EMA about the manufacturing of a yet-to-be-approved biosimilar.

Novartis, which last year received a complete response letter from the FDA for its biosimilar of Amgen’s blockbuster drug Neulasta (pegfilgrastim), has now withdrawn its application in the European Union after regulators raised questions about its biosimilarity, but also manufacturing.

Novartis, which never explained the reason for the FDA’s CRL, also did not announce the withdrawal of the application. Instead, the European Medicines Agency mentioned it in an update

In a more detailed report, the EMA said  study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta. But the other concern was that the plant where the drug was to be manufactured had no certificate of Good Manufacturing Practice (GMP). The EMA said “an inspection of the site will therefore be needed before the medicine can be approved.”


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Novartis told the EMA it was withdrawing the application because it could not respond to the EMA concerns within the prescribed time period. 

Novartis did not respond to requests for comment about where the biosimilar was being manufactured and why the facility was not approved by the EMA. Last year, the Swiss drugmaker said Novartis had invested about $400 million in biomanufacturing facilities in Schaftenau and Kundl, Austria, for the production of biosimilars and other biologic drugs. A spokesperson said Novartis anticipated investing another $600 million through 2020.  

The company in 2015 opened a plant in Schaftenau to manufacture autoinjectors for its one approved biosimilar, Zarxio, a copy of Amgen’s Neupogen, as well as other drugs. Sandoz invested about €150 million ($170 million) in the BioInject facility, which opened with about 100 workers. It has the capacity to manufacture 18,000 and package 100 syringes a minute.

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