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FDA rejects Novartis’ Biosimilar Drug over Amgen’s Original Neulasta

It may not have been immediately obvious but Novartis’ Q2 results contained an important piece of previously unknown information.

The results came out this morning and revealed that the FDA rejected its copycat version of the Neulasta drug, made by Amgen. The biosimilar, which was made by Novartis’ Sandoz unit, applied for the same license as the Amgen drug.

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Neulasta drug is one of Amgen’s top-selling products, with around $5 billion in sales, and much of that revenue stream coming from the U.S. It is used to boost white blood cells in cancer patients that are going through chemotherapy treatment.

In a brief update noted deep down in its results, Novartis said: “Sandoz received a complete response letter [CLR] from the FDA for biosimilar pegfilgrastim candidate (Neulasta). We are working with the agency to address remaining questions.” No further details were given.

This will be a blow to the company and perhaps more widely to other biosim manufacturers, just when it looked like the regulatory side of things was becoming a little more predictable.

Many of the issues this year have revolved around each company trying to block the other with patent disputes; earlier this month, both Novartis and Amgen had seen FDA advisory committees give a unanimous yes to their new, separate biosimilars, with final decisions expected by fall of this year.

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However complete response letters have been sent to other companies such as Pfizer’s Hospira unit. The FDA rejected Hospira’s biosim version of Epugen, Amgen’s kidney disease drug, last year. Both companies have been asked to provide more data before resubmitting their application later this summer.

In 2015 the first biosimilar approval in the United States was granted to Novartis for its copy of Amgen’s Neupogen, another chemotherapy side effects drug. At this stage it is not clear what the Sandoz issues concern, be it worries over manufacturing or clinical trials.

Sandoz previously released a statement when the FDA accepted its application. The unit said that three clinical trials had been carried out on the biosimilar. The first was a pharmacokinetic and pharmacodynamic study in volunteers of full health and two comparative efficacy and safety studies in patients with breast cancer (PROTECT 1 and 2).

It said these “demonstrate that the proposed biosimilar is highly similar to the reference product.” In February the biosim drug was approved by the European Medicines Agency.

Novartis CMO and head of drug development, Vasant Narasimhan, spoke during the Q2 call. “We received the complete response letter from FDA at the end of June. And we have worked closely with the agency throughout this program and are continuing to work with the agency to determine how best answer their questions,” he said, without going into further detail.

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The news is encouraging for Amgen, which has seen its drugs subjected to various biosimilar applications. Even if the Novartis biosimilar is eventually accepted, the recent rejection means that Amgen gets to keep the bounty from Neulasta to itself for at least a while longer.

Peace-lover, creative, smart and intelligent. Prapti is a foodie, music buff and a travelholic. After leaving a top-notch full time corporate job, she now works as an Online Editor for Biotecnika. Keen on making a mark in the scientific publishing industry, she strives to find a work-life balance. Follow her for more updates!