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Date: 2017-04-25

Type of information: Submission of a Market Application 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 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:

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