After FDA rejection, Novartis pulls Amgen biosim candidate from EMA

The move comes around half a year after the FDA sent a complete response letter for the biosimilar.

Back in the summer Novartis quietly announced that the FDA had rejected its application for a biosimilar version of blockbuster drug Neulasta (pegfilgrastim); today, any European reprieve was lost as the Swiss major yanked its application from the EMA after it couldn't show it actually worked, and failing on the manufacturing front. 

In a brief update from the EMA’s drug approval arm, the CHMP, it said: “The application for a marketing authorisation for Zioxtenzo (pegfilgrastim) has been withdrawn. Zioxtenzo was developed as a biosimilar medicine to treat neutropenia in cancer patients.”

The EMA accepted the med for review nearly a year ago, but things have gone awry for Novartis on that front in the intervening 12 months.


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In July, buried deep down in Novartis’ Q2 results, the company said: “Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta). We are working with the agency to address remaining questions.” No further details, however, were given.

This problem was clearly bigger than first thought, given that six months down the line it has decided not to follow through on its EMA app. It’s not clear what prompted the CRL from the FDA, but the EMA gave more color as to what happened on its end. 

“The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions," it said. "The company had not yet responded to the questions at the time of the withdrawal.”

Based on the review of the data the CHMP said it had two main concerns and was of the "provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta."

One concern was 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 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, it said.

The CHMP added: “At the time of the withdrawal, the company had 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.”

In its letter notifying the agency of the withdrawal of the application, the company stated that it “would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure.”

The biosimilar, coming out of its Sandoz unit, was seeking the same license as Amgen’s original med, a long-acting granulocyte colony stimulating factor, which is used to bolster white cells in patients undergoing chemotherapy for cancer. The drug has been one of Amgen's top-selling products, with around $5 billion in sales.

In a statement released in 2015, along with the FDA acceptance for a review, Sandoz said it had conducted three pivotal clinical trials on its biosimilar: one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients (PROTECT 1 and 2).

It said these “demonstrate that the proposed biosimilar is highly similar to the reference product.” Novartis has not commented on its decision. 

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