Coherus' Neulasta biosimilar knocked back by FDA

Dive Brief:

  • The Food and Drug Administration has rejected Coherus BioSciences' biosimilar of Amgen's cancer drug Neulasta (pegfilgrastim), sending shares in the biosimilars-focused company tumbling 24% Monday.
  • Coherus said the FDA requested a reanalysis of some patient samples using a modified assay, as well as for further manufacturing-related process information. On the positive side, the complete response letter issued by the agency did not require an additional clinical study or raise concerns over GMP standards.
  • Coherus hoped to secure approval of CHS-1701 (as its Neulasta copy is known) this quarter and had prepped for a commercial launch to steal market share away from Amgen before other biosimilar competitors moved in.

Dive Insight:

Coherus has already faced delays bringing CHS-1701 to the market. In October 2015, topline results from a pharmacokinetic and pharmacodynamic trial showed a lack of bioequivalence in one of four groups. This led to a decision in December 2015 to carry out a follow-on study, incurring further costs and a roughly three-month delay in filing an application with the FDA.

The biotech eventually submitted its application in October 2016, setting up the FDA's decision this month. Receipt of the complete response letter will delay market entry by around 13 months, according to Coherus executives speaking on an investor call Monday. The timeframe includes the time to schedule a meeting with the FDA, an additional six months to respond to the FDA's requests, and as much as another six months for evaluation of the resubmission.

Coherus didn't see any neutralizing antibodies in its study, so believes that the FDA's ask for a more sensitive assay is aimed at making the dataset more robust. The other manufacturing requests are "not onerous," Coherus said.

While Coherus put a positive spin on the news, the biotech had hoped to take advantage of what it sees as a window of opportunity for biosimilar entry to Neulasta (see January presentation). If CHS-1701 had been approved, Coherus would have enjoyed first bite at Neulasta's sales. Sandoz, Novartis' generics unit, had previously received a complete response letter for its biosimilar version of Neulasta, while the FDA is not expected to issue a decision on Mylan and Biocon's proposed copy until October.

Tracking market adoption of biosimilar copies to Amgen's related Neupogen (filgrastim) product, Coherus also believes the market is receptive to switching from Neulasta.

Amgen has a lot to lose if that comes to pass after any future approvals of a biosimilar copy. Neulasta earned the big biotech $4.6 billion in 2016, with nearly $4 billion of that coming from the U.S. market. Sales growth ticked up 2% year over year in the first quarter.

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Filed Under: Regulatory / Compliance
Top image credit: George Hodan