First US Neulasta Biosimilar Approval on Second Try for Mylan

The FDA has approved the first US biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim). Mylan’s Fulphila is the tenth biosimilar to be approved in the US.

Mylan’s biosimilar, developed with Indian biomanufacturer Biocon, will launch Fulphilia in the coming weeks, spokesperson Julie Knell told BioProcess Insider.

“Mylan is the first company to obtain approval for a biosimilar version of Neulasta in the US. Other manufacturers have sought licensure from the FDA but, to our knowledge, do not yet have approval.”

She added: “Pricing information will be available at launch.”

Manufacturing Issues

The approval came on the second try for Mylan after the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to the firms, citing manufacturing issues at Biocon’s biomanufacturing facility in Bangalore, India.

“The CRL relates to the pending update of the BLA with certain CMC data from facility requalification activities post recent plant modifications,” Biocon said on receiving the letter in October last year. “The CRL did not raise any questions on biosimilarity, pharmacokinetic/pharmacodynamic data, clinical data or immunogenicity.”

Other biosimilar developers have struggled to have their pegfilgrastims approved in the US.

Novartis subsidiary Sandoz received a CRL in 2016 for its pegfilgrastim biosimilar, though the firm did not reveal details of the FDA’s demands.

Coherus last month, meanwhile, resubmitted its biologics license application (BLA) for its biosimilar CHS-1701. The firm had received a CRL in 2017 requesting a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information.

US Biosimilar Approvals to Date

  1. March 2015​: Sandoz’s Zarxio (filgrastim-sndz), a version of Amgen’s Neupogen
  2. April 2016​: Pfizer’s Inflectra (infliximab-dyyb ), a version of J&J’s Remicade
  3. August 2016​: Sandoz’s Erelzi (etanercept-szzs), a version of Amgen’s Enbrel
  4. September 2016​: Amgen’s Amjevita (adalimumab-atto), a version of AbbVie’s Humira
  5. April 2017​: Samsung Bioepis/Merck’s Renflexis (infliximab-abda), a version of J&J’s Remicade
  6. August 2017: Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), a version of AbbVie’s Humira
  7. September 2017: Amgen and Allergan’s Mvasi (bevacizumab-awwb), a version of Roche’s Avastin
  8. December 2017: Mylan and Biocon’s Ogivri (trastuzumab-dkst), a version of Roche’s Herceptin
  9. December 2017: Pfizer’s Ixifi (infliximab-qbtx), a version of J&J’s Remicade
  10. June 2018: Mylan and Biocon’s Fulphila (pegfilgrastim-jmdb), a version of Amgen’s Neulasta

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