Accord’s biosimilar Pelgraz poised for approval

Cancer biosimilar drug Pelgraz is poised to hit the market after receiving a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).

Accord Healthcare’s Pelgraz could become the first pegfilgrastim biosimilar to be launched in Europe once it is fully approved by regulators.

The drug is used to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy. Neutropenia is an abnormally low number of neutrophils – white blood cells that usually fight off bacterial infections and fungi. Patients undergoing chemotherapy are particularly prone to developing neutropenia while their cell counts replenish.

Dr Paul Cornes, consultant oncologist, Bristol NHS Foundation Trust, said, “Pegfilgrastim is a wonderful medicine. It enables cancer chemotherapy to be given on time and at the right dose – giving patients the greatest chance of an uncomplicated cure.

“As a single injection for each cycle of chemotherapy it offers advantages in dosing and compliance over first generation short-acting filgrastim - which results in real world improvements for patients.”

Pelgraz is a pegylated granulocyte-colony stimulating factor (G-CSF), a type of growth factor that stimulates bone marrow to produce white blood cells following a course of chemotherapy. Pegylated G-CSF stays in the body for longer than with the other types of G-CSF, meaning patients need fewer treatments.

So beneficial is the use of these drugs that the World Health Organisation considers G-CSF essential therapies due to their impact on febrile neutropenia, chemotherapy dose delays, and dose density.

The CHMP positive opinion was based on Pelgraz’s clinical development programme, which supported its biosimilarity with Amgen’s 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).

Paul Tredwell, vice-president of speciality brands at Accord (EMENA), said the company’s mandate is to deliver affordable medicines that make a significant difference to patients’ lives.

“With Pelgraz approval and commercialisation, we hope to provide patients with the first pegylated biosimilar of pegfilgrastim that will reduce the strain on healthcare providers budget, while potentially improving standard of care and associated outcomes for patients.”

Last month, the US Food and Drug Administration (FDA) approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Neulasta for febrile neutropenia in patients with non-myeloid cancer, who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.