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Date: 2017-06-12

Type of information: Refusal of a Market Autorisation in the US

Product name: CHS-1701 - biosimilar version of pegfilgrastim

Compound: biosimilar version of pegfilgrastim

Therapeutic area: Cancer - Oncology

Action mechanism: protein/biosimilar. Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF).

Company: Coherus BioSciences (USA - CA)

Disease: reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients

Latest news:

  • • On June 12, 2017, Coherus BioSciences announced that the FDA has issued a complete response letter for its biologics license application for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway. The CRL primarily focused on the FDA request for a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information. The FDA did not request a clinical study to be performed in oncology patients. Additionally, the CRL does not indicate additional process qualification lots would be required or raise concerns over the GMP status of CHS-1701 bulk manufacturing and fill-finish vendors. Coherus will work with the FDA to address the information requests.
  • • On November 29, 2016, Coherus BioSciences announced acceptance of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This represents the first EMA submission and acceptance for Coherus BioSciences. The CHS-1701 MAA is supported by biosimilarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta.
  • • On October 6, 2016, Coherus BioSciences announced that the FDA has accepted the filing of 351(k) Biologics License Application for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta®. The biosimilar user fee act (BSUFA) action date is June 9, 2017.
  • • On August 9, 2016, Coherus BioSciences, announced submission of the biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, to the FDA under the 351(k) pathway. The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 and Neulasta®.

Patents:

  • • On April 25, 2017, Coherus BioSciences announced that it completed the initial phases of the Biologics Price Competition and Innovation Act (BPCIA) patent exchange procedure with Amgen for Coherus’ Neulasta (pegfilgrastim) biosimilar candidate, CHS-1701. Of the two patents originally listed by Amgen in the process, the parties have reached agreement on a single patent for potential litigation, U.S. patent 8,273,707 (the ‘707 patent), directed to a method for purifying the product. Under the provisions of the BPCIA patent dance, Amgen is subject to a 30-day deadline, expiring on May 11, 2017, to file a patent infringement suit against Coherus under the ‘707 patent. Failure to do so will result in Amgen’s loss of injunctive rights under the patent, limiting any potential recovery to monetary damages. Litigation has not yet been initiated.
 

Submission of marketing authorization application USA : 2016-08-09

Submission of marketing authorization application UE: 2016-11-29

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes