Type of information: Granting of a Market Authorisation in the US
Product name: Udenyca® - CHS-1701 - pegfilgrastim
Compound: pegfilgrastim - biosimilar version of Neulasta®
Therapeutic area: Cancer - Oncology
- protein/biosimilar. Udenyca®, formerly CHS-1701, is a biosimilar candidate to pegfilgrastim, a growth-colony-stimulating-factor (G-CSF) designed to decrease the chance of infection as manifested by febrile neutropenia in patients with non-myeloid (non-bone marrow) cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.
Company: Coherus BioSciences (USA - CA) - ERA Consulting (Germany)
- reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients
- • On November 2, 2018, Coherus BioSciences announced that the FDA has approved Udenyca™ (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. The approval of Udenyca™ was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects. The European Commission approved Udenyca™ on September 21, 2018.
- • On July 26, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Udenyca®, a pegfilgrastim (Neulasta®) biosimilar candidate, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. Udenyca® will be available as a 6-mg solution for injection. Udenyca®'s marketing authorization application to EMA is supported by analytical similarity data, a 3-arm, triple-crossover pharmacokinetic (PK) and pharmacodynamics (PD) study in healthy subjects, as well as a robust immunogenicity package including a dedicated immunogenicity study in over 300 subjects. The biosimilar is currently under evaluation by the FDA with an action date expected on or before November 3, 2018.
- • 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®.
- • 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: 2018-11-02
UE authorization: 2018-09-21
Favourable opinion UE: 2018-07-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: