The Battle Between Biosimilars and Neulasta

James Radke

Monday was a good news and bad news day for Amgen and its drug, Neulasta (filgrastim).
First, the good news:  The U.S. Food and Drug Administration (FDA) sent a Complete Response Letter to Coherus BioSciences regarding the company’s CHS-1701, a Neulasta biosimilar candidate.
According to Coherus, the FDA requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. 
Coherus plans to work with the FDA to address the information requests.
“While we are disappointed in the delay that this additional request has caused, we remain confident in our ability to address the FDA’s requests for the purpose of obtaining approval for CHS-1701,” said Denny Lanfear, President and CEO of Coherus BioSciences.  “We are encouraged that a patient study has not been requested and we expect that we will be able to respond to the FDA and meet with them to define a path forward in the coming months.  Neulasta is the largest selling oncology biologic in the U.S., and we anticipate CHS-1701’s approval will generate significant U.S. healthcare savings while increasing patient access.”
Now, the bad news: the U.S. Supreme Court voted 9-0 that Sandoz did nothing wrong in marketing their Neulasta biosimilar drug, Zarxio, starting in 2015. The court ruling does not directly impact Amgen’s Neulasta future sales but the company was arguing that they should have had an additional 6 months of exclusivity before Zarxio went to market. The Supreme Court disagreed.
The court ruling is in reference to a section of the 2010 Affordable Care Act. In 2015, U.S. Court of Appeals for the Federal Circuit in Washington handed Amgen an extra 6 months of exclusivity on top of the 12 years already provided under the law, though the Supreme Court would eventually overrule that lower court decision.
Justice Clarence Thomas wrote the court’s opinion that Sandoz did legally provide Amgen with 6 months notice that it would market the drug when approved. Amgen, for its part, using various state laws and congressional statements, argued that the 6 months applies to when the drug is approved, not necessarily when the drug is submitted to the FDA for approval or the drug’s patent is submitted.
Neulasta, first approved in 1991, is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology. In 2015, the drug was approved for the orphan indication to increase
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