Type of information: Granting of a Market Authorisation in the EU
Product name: Pelgraz®
Compound: pegfilgrastim - biosimilar version of Neulasta®
Therapeutic area: Cancer - Oncology - Infectious diseases - Transplantation
- protein/biosimilar. Pelgraz® is a biosimilar version of Neulasta® (pegfilgrastim), a pegylated form of the human granulocyte colony stimulating factor (G-CSF) analogue filgrastim
Company: Accord Healthcare Ltd (UK) wholly owned subsidiary of Intas Pharmaceuticals (India)
- reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes)
- • 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 Pelgraz®, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.
Pelgraz® will be available as a 6-mg solution for injection.
- The CHMP positive opinion was based on Pelgraz's substantial clinical development programme, which supported its biosimilarity with Neulasta® through a Phase I, randomised, assessor-blinded PK/PD study in healthy volunteers, and a Phase III study of patients with breast cancer (stage IIa, IIb, or IIIa) on TAC (docetaxel, doxorubicin, cyclophosphamide).
- Intas / Accord will manufacture Pelgraz in its own state of the art production facility.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
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: