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6 Jan 2015

The first attempt in the United States to bring biosimilar

Novartis AG biosimilar, is “highly similar” to Amgen Inc.’s  blockbuster cancer medicine Neupogen, Food and Drug Administration staff said today in a report. FDA advisers will consider the report when they meet Jan. 7 to make a recommendation on whether the biosimilar should be approved for all five conditions Neupogen is sold to treat, most which help increase the white cell blood count of cancer patients.

Neupogen, which generated an estimated $1.2 billion in sales for Amgen in 2014, is part of the growing class of biologic medicines, which are more complex than chemical drugs. They also are typically more expensive and, unlike chemical drugs, have never faced generic competition before. The U.S. may save at least $44 billion in drug spending in the next 10 years by introducing biosimilars, according to Rand Corp.

FDA staff said Novartis’s data suggest the biosimilar should be approved for all five conditions. The report said there is some data pending that may be available for the adviser meeting.

Novartis’ biosimilar version of Neupogen “meets the requirement for a demonstration of ‘no clinically meaningful differences’ between the proposed product and the reference product in terms of safety, purity, and potency,” FDA workers said.

The regulatory body can now approve biosimilars under the Patient Protection and Affordable Care Act 2010, as imitations of drugs can be developed that are not precisely identical but are cheaper than the originals. In Europe, regulators have been approving imitation drugs since 2006. A biosimilar for Neupogen was approved for sale in Europe in 2008.

In December 2014, Novartis’ generic drug unit Sandoz announced topline results from Phase-II study of Neupogen’s imitation drug to prevent infections for cancer patients who go through chemotherapy. The results demonstrated efficacy, similar to that of the original drug, which costs $3000-7000 for a single dose.

Neupogen contributed $1.2 billion to Amgen’s revenues in 2014. It is developed from living cells and cannot exactly be copied. However, it can be imitated legally.

Neupogen is among the 14 expensive biotech drugs that do not have any generic competitors in the US, and which are being targeted by pharmaceuticals that plan on selling cheaper versions, as reported by regulators. Neupogen’s US patent expired in December 2013.

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