With successful preapproval inspections at its manufacturing sites, Coherus BioSciences is confident its CHS-1701 pegfilgrastim biosimilar will be approved by the end of the year.
In 2017, California-based Coherus received a US Food and Drug Administration (FDA) complete response letter (CRL) for its version of Amgen’s Neulasta (pegfilgrastim), CHS-1701.
The CRL requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information.
Earlier this month, Coherus announced it resubmitted its biologics license application (BLA) for the biosimilar candidate, and on a call Friday the firm said it expects to receive FDA acknowledgement by early June and “approval which we believe will occur on or before November 3.”
Meanwhile the firm is looking to submit a European filing the day-180 responses by the end of May.
The firm has realigned its internal organization and recently appointed Vince Anicetti as chief operating officer with full responsibility for manufacturing quality and supply chain logistics.
“Both our drug substance and drug product manufacturing sites for both US and Europe, both successfully passed their preapproval inspections,” Anicetti said on the call. “There were a few minor observations in each case, and both of those have been formally responded to.”
He added the response was accepted by both EMA and FDA. “We don’t anticipate any further inspections as part of this resubmission process, but we are prepared nonetheless as we may have routine GMP inspections at those sites in the future.”
Neulasta clocked in sales of around US$4.65 billion globally for Amgen in 2018.
Coherus CEO Denny Lanfear said, if approved, CHS-1701 could capture up to 75% of the market in the long-term. This will, of course, depend on the number of competitors in the space.
Currently there are no approved biosimilar versions of the PEGylated form of the recombinant human granulocyte colony-stimulating factor analog filgrastim.
Last October, Indian drugmakers Mylan and Biocon received a CRL for its version of Neulasta, MYL-1401H, due to manufacturing issues at the latter’s facility in Bangalore, India.
“The CRL relates to the pending update of the BLA with certain CMC [chemical manufacturing control] data from facility requalification activities post recent plant modifications,” Biocon said a Bombay Stock Exchange filing.
And Novartis subsidiary Sandoz too received a CRL in 2016 for its pegfilgrastim biosimilar, though the firm did not reveal details of the FDA’s demands.