EMA Concerns Prompt Sandoz to Withdraw Neulasta Biosimilar Application

Christina Mattina
February 02, 2017
Sandoz has pulled its pegfilgrastim biosimilar application from consideration by the European Medicines Agency (EMA) after the agency’s Committee for Medicinal Products for Human Use (CHMP) responded to the initial submission with a list of questions. Zioxtenzo, which was intended as a biosimilar for Amgen’s Neulasta, was rejected by the FDA in July 2016.

Last February, Sandoz—a Novartis subsidiary—presented study results to the CHMP aiming to show that Zioxtenzo could treat neutropenia in cancer patients with the same safety and effectiveness as Neulasta, but the committee was not convinced. After evaluating the documentation, the CHMP determined that it could not approve the drug as a biosimilar based on 2 primary concerns.

First, the trial results failed to show that Zioxtenzo produced comparable blood levels of pegfilgrastim, the drug’s active substance that works similarly to the human protein granulocyte-colony-stimulating factor that fights neutropenia by encouraging bone marrow to make more neutrophils. Neutropenia is common in patients receiving chemotherapy and can result in fever and serious infections.

The second concern of the CHMP was that the drug’s manufacturing site did not have a certificate of Good Manufacturing Practice, which is awarded to manufacturers that meet certain standards of quality assurance, personnel qualifications, accurate documentation, labelling practices, and clean premises and equipment. The CHMP said that it would need to inspect the site before Zioxtenzo could be approved.
However, Sandoz chose not to prepare for this inspection and instead withdrew its application completely. In a letter to the chair of the CHMP explaining the decision, the company said that it would “not be able to provide the additional information required by the CHMP within the regulatory timeframe for this procedure.” The letter indicated, however, that Sandoz would continue its ongoing clinical trials and left the door open for future resubmissions after it had addressed the committee’s concerns.

The withdrawal followed a similar disappointment in July, when Sandoz received a complete response letter from the FDA indicating that Zioxtenzo had not been approved. Novartis said in an announcement that it was “working with the agency to address remaining questions,” though it did not elaborate on the nature of the FDA’s concerns.

Sandoz, the generic subsidiary of Novartis, became the first to enter the US biosimilar market when the FDA approved its filgrastim biosimilar Zarxio in 2015. It has vowed to launch 4 additional biosimilars by 2020, including Zioxtenzo.
 

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