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CHMP approves pegfilgrastim biosimilar, Pelgraz from Accord/Intas

Pelgraz – a pegylated G-CSF biosimilar, is latest addition to Accord Healthcare’s established portfolio of over 30 oncology treatments across Europe.

Following marketing authorisation Accord Healthcare will potentially be the first to launch pegfilgrastim across Europe.

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Accord’s Pelgraz (pegfilgrastim), pegylated granulocyte-colony stimulating factor (G-CSF) biosimilar in Europe. Once approved, Pelgraz could be the first pegfilgrastim biosimilar to market in Europe indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy. The World Health Organisation consider G-CSF essential therapies due to their impact on febrile neutropenia, chemotherapy dose delays, and dose density.

Intas / Accord will manufacture Pelgraz in its own state of the art production facility. The company has deep experience with biosimilar medicines and as of 2017 were assessed as having the second highest number of biosimilars in phase III to approval in the world. This reflects the strategy of a long-standing commitment in biopharmaceutical development, research and manufacturing.

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).

Source: Intas Press release