Novartis (NYSE:NVS) Withdraws Application For Amgen Biosimilar Candidate From EMA

In the last summer, Novartis (NYSE:NVS) did not make much ho-hum about the fact that its application for the doppelganger drug of Neulasta (pegfilgrastim) was rejected by the U.S. FDA. However, in a latest bid, the company’s hope from the EU also crashed. In a recent update, the drug approval body of EMA or European Medicine Agency, CHMP (Committee for Medicinal Products for Human Use) told about withdraw of the application for Zioxtenzo (pegfilgrastim).

Novartis withdraws application from EU

In a 2-line update, CHMP said, “The application for a marketing authorisation for Zioxtenzo (pegfilgrastim) has been withdrawn. Zioxtenzo was developed as a biosimliar medicine to treat neutropenia in cancer patients.”

So, Novartis’ fate in EU sits in these two lines beneath the column “Withdrawals of applications.” About one year ago, the European Medicine Agency had accepted Zioxtenzo for review. But, the drug got no approval in FDA and since then, things went downhill for the company.

Then in July, last year, Novartis said that its drug, Sandoz had received FDA’s response letter for biosimilar pegfilgrastim candidate, Neulasta. During that time, when company had announced its Q2 2016 results, it had said that they were working with the FDA for addressing the questions. But, no updates have been forwarded since then.

Where does the problem sit?

CHMP provided the company, with the data on the basis of its review. The problem was “provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.” Now, one o f the problems was that the study results failed to show that pegfilgrastim concentration in blood was at the same level after being administrated with Zioxtenzo and Neulasta. Secondly, the company did not have Good Manufacturing Practice (GMP) certificate for the production of medicine at the manufacturing site.

Novartis did not say anything to the matter. On 30 January 2017, the company’s shares fell 0.42%, running at 71.60CHF.

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