Novartis biosimilar takes aim at Amgen drug Neulasta

[November 18, 2015] ZURICH (Reuters) - The U.S. Food and Drug Administration has accepted Novartis unit Sandoz's submission for approval of a biosimilar version of U.S.-based Amgen's Neulasta drug that fights infections in cancer patients, the Swiss group said on Wednesday.

It marks the company's third biosimilar filing in the United States and the second of 10 regulatory filings planned over the next three years, it said in a statement.

Sandoz said it would seek the same indication as Neulasta, whose generic name is pegfilgrastim.

Amgen's third-quarter results last month showed sales of Neulasta up 6 percent to $1.26 billion, topping expectations of $1.17 billion.

The FDA last month accepted Sandoz's regulatory submission for approval of a biosimilar copy of Amgen's blockbuster Enbrel drug.

Biosimilars aim to copy biologic products, which are made inside living cells, but they can never be exact duplicates, so biosimilar manufacturers need to conduct clinical trials to show their products work as intended.

"Sandoz believes that the totality of evidence in its submission, including three pivotal clinical studies, will demonstrate that the proposed biosimilar is highly similar to the reference product," it said on Wednesday.

Novartis in September launched the first biosimilar drug in the United States after a U.S. appeals court declined to stop the sale of the company's copycat version of Amgen's blockbuster cancer drug Neupogen.

Insurers and government healthcare systems hope biosimilars will cost the public 40 percent to 50 percent less than the original drugs and experience in Europe suggests that steep discounts are being offered in some markets.

The potential for biosimilars to take a large slice of the market is grabbing the attention of both healthcare providers, who see big budget savings, and investors, worried about the impact on the profits of companies making original products.

(Reporting by Michael Shields; Editing by Muralikumar Anantharaman)

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