Amgen Gains Positive CHMP Opinion for Neulasta Onpro as Pegfilgrastim Biosimilar Competition Draws Closer

This week, Amgen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label variation for its reference pegfilgrastim to now include the branded Neulasta Onpro Kit. Following the CHMP positive opinion, the centralized European marketing authorization of reference pegfilgrastim will be updated to include the delivery system of the device in its label.

The Onpro Kit device uses pegfilgrastim in an on-body injector that allows a patient to forego a visit to the physician’s office to receive an injection of the drug.

“The Neulasta Onpro Kit is a showpiece of our patient-centric approach and continued investment in advancing the field of G-CSF administration,” said David M. Reese, MD, senior vice president of translational sciences and oncology at Amgen, in a statement.

The Onpro Kit has been approved in the United States since August 2015, and can be very costly. The eventual introduction of pegfilgrastim biosimilars into the marketplace could provide competition to the reference product due to lower prices, but the convenience provided by the on-body device could help Amgen to retain its market share for the reference drug.

Meanwhile, Gedeon Richter, a German-based pharmaceutical company, announced today that the EMA has accepted its resubmission of a marketing authorization application (MAA) for a proposed pegfilgrastim biosimilar.

In December 2016, following a meeting with the CHMP, Gedeon Richter withdrew its MAA due to committee concerns that the data provided did not allow for a positive benefit-risk assessment.

Gedeon Richter made the decision to resubmit its application to the EMA after completion of an additional clinical study that provided data demonstrating similarity of both the pharmacokinetics and pharmacodynamics of the proposed biosimilar and reference Neulasta.