The European Medicines Agency (EMA) issued a positive opinion last week recommending a label variation for Neulasta (pegfilgrastim) to include the Neulasta Onpro Kit, an on-body injector (OBI) timed delivery system.
“The Neulasta Onpro Kit is a showpiece of our patient-centric approach and continued investment in advancing the field of G-CSF [granulocyte-colony stimulating factor] administration,” David Reese, senior vice president of Translational Sciences and Oncology at Amgen said.
“This improved administration option not only provides patients with the freedom and independence they seek, but the optimally timed delivery gives peace of mind to physicians and caregivers knowing it helps fight the risk of infection.”
The positive opinion is the latest regulatory development for Amgen’s Neulasta, first approved in Europe in 2002 for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy.
The system has been available in the US since August 2015.
The approval of Neulasta Onpro Kit could help stave off upcoming pegfilgrastim biosimilar competition as delivery devices and formulations can give biologics a competitive edge.
For example, Roche, which is beginning to see competition eat away at its bestselling biologics, has formulated subcutaneous versions of Herceptin (trastuzumab) and Mabthera (rituximab). Meanwhile AbbVie’s interest in delivery device systems has been seen as one way of reducing the impact of biosimilars on its topseller Humira (adalimumab).
While there are so far no biosimilar versions of Neulasta on the market, there are a number of companies looking to enter the space. Mylan and Biocon’s MYL-1401H was rejected in a complete response letter (CRL) by the US Food and Drug Administration (FDA) last year, while Sandoz withdrew its candidate in February 2017 after the EMA cited GMP concerns.
Versions of Amgen’s non-PEGylated G-CSF drug Neupogen (filgrastim) have been approved both in Europe and the US, and sales of the reference product have been affected.