Was a cannibalization scheme at perform in Amgen’s troubled advertising for the Onpro wearable pegfilgrastim injector? In a cannibalization ploy, the manufacturer will attract income absent from an present product to assist advancement of revenues for a observe-on item.
In this situation, Amgen’s promoting promises manufactured the Onpro pegfilgrastim injector appear to be excellent in efficacy to its longstanding Neulasta prefilled syringe (PFS). In a warning to Amgen not too long ago, the Fda stated the proof supporting this claim was weak, and the company lifted considerations that the marketing would weaken general public faith in pegfilgrastim biosimilars, all of which are in a PFS.
“If Amgen thinks that the way to go is to cannibalize its Neulasta PFS for the Neulasta Onpro gadget with an assessment subjected to a lot of opportunity biases, I really don’t feel that they’ll get substantially of a listening to from the pharmacy and therapeutics [P&T] committees,” mentioned Ivo Abraham, PhD, a professor in the Division of Pharmacy Apply at the University of Arizona, who has carried out a number of scientific studies into the worth of pegfilgrastim in the cancer treatment supportive placing. P&T committees are the medical teams that make conclusions about which medicine to use in healthcare establishments.
Pegfilgrastim is a very long-acting granulocyte colony stimulating component (GCSF) utilised to spur the progress of neutrophils and ward off the progress of febrile neutropenia (FN) in people receiving chemotherapy.
Onpro Advertising Promises
In advertising for the Onpro, Amgen relied upon details that described a 31% bigger incidence of FN amid clients working with PFS vs Onpro types of pegfilgrastim software. As the Food and drug administration pointed out, that was in fact the difference in between 2 extremely reduced proportions of clients who seasoned FN and the obtaining was not statistically considerable, this means no trustworthy clinical inference could be produced from it.
Individually, a Sandoz research evaluated for attainable reduction in FN incidence in between the Onpro and PFS pegfilgrastim, which also located no statistical importance. The incidence of FN in the preliminary cycle of chemotherapy was 1.01% for Onpro vs 1.48% for PFS (P = .336). In all chemotherapy cycles, FN incidence was .91% for Onpro vs 1.22% for PFS (P = .214).
The Fda located other difficulties with the Amgen review, stating there was sturdy potential for bias in range of individuals and a failure to determine the sensitivity of the details resources.
A Pandemic Celebrity
The Onpro proved its well worth to Amgen through the pandemic as it allowed individuals going through chemotherapy to receive their adhere to-up pegfilgrastim injections at property. PFS biosimilars at the moment keep a 35% current market share of the pegfilgrastim industry, but the Onpro however retained a 54% share of the overall industry at the end of the first quarter of 2021. General gross sales of Neulasta, in the meantime, experienced declined 21% for the calendar year finished March 31, 2021, in accordance to Amgen.
On the other hand, the dynamics of the pegfilgrastim industry are altering and it may possibly come to be difficult for Onpro to keep its dominance. Pegfilgrastim is a extensive-performing agent that is administered the moment for each chemotherapy cycle at a price of around $6200 for each injection. There is evidence that payers are sometimes preferring to use filgrastim, a further GCSF that is administered everyday at a lessen value of about $360 for each injection. Further more, the range of filgrastim injections in a the latest research averaged all-around 5, which indicates that comparatively talking, filgrastim can be administered for much much less than pegfilgrastim.
A further development has to do with the administration of PFS. It is starting to appear that pegfilgrastim can be securely administered on the same working day as chemotherapy, obviating the need to have for dwelling-primarily based or stick to-up injections, Abraham pointed out.
In a modern research of clients with lymphoma acquiring CHOP chemotherapy (cyclophosphamide/hydroxydaunorubicin/vincristine [Oncovin], prednisone), investigators concluded pegfilgrastim (Udenyca) can be properly administered on the similar day as the CHOP chemotherapy.
“This examine from the College of Arizona Cancer Heart confirmed that administration of pegfilgrastim on the very same day as chemotherapy is a protected, helpful method of preventing FN in people who acquire common-of-treatment chemotherapy to deal with lymphoma,” investigators concluded.
“While the pegfilgrastim label implies that this progress factor should really not be injected just before the 24-hour to 72-hour time window, there is increasing proof, some from controlled trials—including a set sponsored by Amgen—and more from noncontrolled research, that exact-working day administration may well be a secure and successful choice through remedy with chemotherapy. In addition, there is first evidence that eflapegastrim, a novel GCSF, administered the exact same day as chemotherapy may be protected and powerful,” Abraham reported.
And finally, no matter whether there is a lower incidence of FN with the Onpro vs PFS pegfilgrastim, reports have proven failure rates with the Onpro ranging from 1.7% to 6.9%, which means that these proportions of sufferers enrolled in trials failed to receive correct dosing of pegfilgrastim from the Onpro.
“When the device fails, the affected person may not have received any or all of the necessary prophylaxis, and for that reason may perhaps be at higher chance of chemotherapy-induced FN and its numerous implications, including hospitalization or demise,” Abraham explained.
Time to Shift On?
In Abraham’s view, Amgen has reworked supportive oncology treatment as a result of the growth of Neupogen (filgrastim) and Neulasta, but it’s time for Amgen to build new and far more effective solutions, using its major pharmaceutical source base, and allow competitiveness and market dynamics to consider about the pegfilgrastim market place and make this agent a lot more affordable and a lot more commonly readily available.
“Amgen’s advancement issue innovation has specified clinicians effective implies of combating the effects of myelosuppressive chemotherapy, enabling far better and extra sustained chemotherapy. Just as much, it has reduced individual struggling and has improved medical outcomes and quality of life.
“But there is also the a lot-required patent process: It assisted Amgen establish and industry expansion aspects with the safety afforded by the patent system. That protection has finished and biosimilar competitors for market place share is now a world truth,” he claimed.