EMA Recommends Granting a Marketing Authorisation for Biosimilar Pegfilgrastim

Biosimilar medicines Pelgraz and Udenyca are intended to reduce duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy

On 26 July 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorisation for the medicinal products Pelgraz and Udenyca, intended to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy. 

The applicant for Pelgraz is Accord Healthcare Limited. 

The applicant for Udenyca is ERA Consulting GmbH. 

Both, Pelgraz and Udenyca will be available as a 6-mg solution for injection. 

The active substance of Pelgraz and Udenyca is pegfilgrastim, an immunostimulant (ATC code: L03AA13) that belongs to the class of haematopoietic growth factors (granulocyte-colony stimulating factor; G-CSF) which increase the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells. 

Pelgraz and Udenyca are biosimilar medicinal products. They are highly similar to the reference product Neulasta (pegfilgrastim), which was authorised in the EU on 22 August 2002. Data show that Pelgraz and Udenyca have comparable quality, safety and efficacy to Neulasta. 

The full indication for each, Pelgraz and Udenyca is: 

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). 

It is proposed that Pelgraz and Udenyca be initiated and supervised by physicians experienced in oncology and/or haematology. 

Detailed recommendations for the use of these products will be described in the summary of product characteristics, which will be published in the European public assessment reports and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission. 

Summaries of positive opinions are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinions.