Date: 2018-09-20
Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Ziextenzo®
Compound: pegfilgrastim - biosimilar version of Neulasta®
Therapeutic area: Cancer - Oncology
Action mechanism:
- protein/biosimilar.Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF).
Company: Sandoz (Switzerland)
Disease: reduction of the duration of neutropenia and the occurrence of febrile neutropenia in cancer patients
Latest news:
- • On September 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive
opinion, recommending the granting of a marketing authorisation for Ziextenzo®, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to
chemotherapy. Ziextenzo® will be available as a 6-mg solution for injection.
- • On February 11, 2016, Sandoz announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for its biosimilar to Amgen’s Neulasta®* (pegfilgrastim) – a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product, i.e. reduction of the duration of neutropenia in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes). Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients – is expected to satisfy the regulatory requirements for demonstrating high similarity to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product’s indication.
- Pegfilgrastim was recently accepted by the FDA for regulatory filing, making this announcement the fifth of 10 that the company plans to make over a three-year period (2015-2017).
- • On November 18, 2015, Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s Neulasta® .Sandoz is seeking approval for the same indication as the reference product .In the US, the incidence of febrile neutropenia is estimated to be more than 60,000 a year, accounting for nearly eight cases per 1,000 cancer patients. Approximately 1.6 million people per year in the US develop non-myeloid cancer .Sandoz plans to make ten planned regulatory filings over the next three years.
Patents:
Submission of marketing authorization application USA :
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: 2018-09-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
