FDA rejects Coherus'
biosimilar for Amgen's Neulasta
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[June 12, 2017] (Reuters)
- Coherus BioSciences Inc said on Monday
the U.S. Food and Drug Administration (FDA) denied the approval of its
biosimilar for Amgen Inc's blockbuster treatment, Neulasta, which fights
infections in cancer patients.
Coherus' shares fell nearly 25 percent to $15.50 in trading before
The biosimilar, CHS-1701, is among Redwood City, California-based
Coherus' lead experimental drugs.
The FDA's response comes as Amgen gears up for biosimilar
competition for Neulasta, which generated about $4.6 billion in
sales last year.
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.
The FDA requested Coherus for a re-analysis of certain data and
asked the drug developer for more manufacturing information, Coherus
said, adding that it would work with the agency to address the
Amgen's shares were up about 1 percent at $165.75 in premarket
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(Reporting by Divya Grover in Bengaluru; Editing by Saumyadeb
Chakrabarty and Sai Sachin Ravikumar)
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