
Amgen: Neulasta Safe for Now; Dose Accuracy of Erenumab a New Focus
Amgen discussed the drug-delivery approaches to two of its biologics in a recent second-quarter earnings call.
Amgen executives don’t seem too concerned that a viable competitor to the company’s Neulasta (pegfilgrastim) franchise will threaten its
Neulasta is a granulocyte colony-stimulating factor that is used to treat neutropenia in patients receiving chemotherapy. Although Sandoz submitted a biosimilar application to FDA in November 2015 for Neulasta, the company recently said in a second-quarter media release that it received a complete response letter from FDA rejecting the application. Meanwhile, the European Medicines Agency agreed to review Mylan/Biocon's biosimilar to pegfilgrastim on July 22, 2016.
Dose accuracy key to chronic migraine medications
Amgen may rely on an innovative drug-delivery system to eventually market its investigational treatment for chronic migraines as well. It is co-developing
Sean Harper, executive vice-president of R&D, said that he has not seen “any data to suggest that [currently available CGRP inhibitors] are different from one another with respect to what they can achieve when they are dosed and saturating quantity.” Thus, he says, a competitive advantage could lie with how easily administered the antibody is and what would be the minimal dose that would still be effective. Harper concluded, “Let's say we believe a monthly subcutaneous disposable auto-injector would be a very nice solution to this otherwise healthy active type of population.”
Source: Seeking Alpha
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