- FDA does not ask Coherus for additional trial
June 12 (Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration (FDA) did not approve its biosimilar version of Amgen Inc's blockbuster treatment, Neulasta, which fights infections in cancer patients.
Shares of Coherus tumbled 34 percent to $13.70 in trading before the bell.
The FDA's response comes as Amgen expects biosimilar competition for Neulasta by the fourth quarter of 2017. The treatment generated about $4.6 billion, or a fifth of the U.S. biotech's total sales last year.
The agency did not ask Coherus to conduct another trial, but requested a re-analysis of some existing data and more manufacturing information, the company said on Monday, adding that it would work with the agency to address the requests.
The FDA last year declined to approve Novartis AG's biosimilar copy of Neulasta, while Mylan NV and Biocon Ltd are expecting a decision on their Neulasta biosimilar by October.
Biosimilars aim to copy biologic drugs, which are made inside living cells, but they can never be exact duplicates, so manufacturers of biosimilars need to conduct clinical trials to show their products work as intended.
Developing biosimilars requires considerable expertise and is relatively costly, but the field is attracting growing investment as many blockbuster biotech medicines start to go off patent.
Redwood City, California-based Coherus' Neulasta biosimilar, CHS-1701, is among its lead experimental drugs. The company is also developing biosimilars for AbbVie Inc's rheumatoid arthritis drugs, Enbrel and Humira.
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