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FDA rejects Novartis’ biosim app for Amgen blockbuster

FDA rejects Novartis’ biosim app for Amgen blockbuster

Buried deep down in Novartis’ ($NVS) Q2 results out this morning was a previously unknown rejection by the FDA for its copycat version of Amgen’s ($AMGN) blockbuster drug Neulasta (pegfilgrastim).

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 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.

But for the first time, Novartis has in its second quarter update said that the FDA rejected its biosim application for the drug, which was accepted by the regulator last November. The review was designed to last 10 months.

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.

But there has been a CLR for other companies, notably for Pfizer’s ($PFE) new Hospira unit, which saw its biosimilar version of Amgen’s kidney disease drug Epogen (epoetin alfa) being rejected last year. The FDA asked the companies for more data from their application with a resubmission planned for this summer.

Novartis was in fact the first company last year to gain a biosimilar approval in the U.S. (there have been biosims in Europe for around a decade) with its copy of Amgen’s other chemo side effects drug Neupogen (filgrastim)–a slightly differnt formulation of Neulasta.

It is unclear what the Sandoz CRL refers to, and whether the issues are to do with a clinical trial or manufacturing concerns.

In a statement released last year along with the FDA acceptance, Sandoz said it had conducted 3 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.” The biosim drug was also accepted by the European Medicines Agency back in February.

Novartis did not immediately return a call to FierceBiotech.

Originally posted on

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