The doctors join AbbVie, Genentech and Amgen in calling for new non-proprietary names for biosimilars, in what is shaping up to be a vicious fight that pits pharmacists, retirees and GPhA against them.
In their letter to FDA commissioner Margaret Hamburg, the physicians note that “even the same brand of medicine made by the same manufacturer, let alone similar medicines made by different manufacturers, may cause different reactions among patients with the same medical diagnoses and similar physical characteristics.”
In arguing for the separate names, the physicians say that distinct nonproprietary names will help to alert physicians that each product, while safe and effective, “may differ slightly.” EU member states previously said such caution may undermine the trust that physicians have in prescribing biosimilars.
“Rather than deter physicians from prescribing these products, we believe that allowing physicians to know the exact product that they are prescribing will increase confidence, thus encouraging more robust utilization of biosimilars than may develop without this transparency,” the physicians say, noting that a recent survey of physicians who prescribe biologics and biosimilars in Europe indicated that 61% of the respondents believed that if two products shared an International Nonproprietary Name (INN), they were approved for all of the same indications.
“This is not necessarily the case and a misunderstanding can be potentially dangerous,” the physicians say.
Distinguishable names also “will help prevent inappropriate pooling of adverse events by clearly identifying which product a patient was prescribed,” according to the physicians, some of whom belong to organizations, such as the Alliance for Patient Access, which have associate members that include Big Pharma and biotech companies.
Although National Drug Code (NDC) numbers can identify the manufacturer of a given medication or biosimilar, “this information is not readily available to the treating physician. It is critical with medicinal molecules of this size and complexity, and with such potential for immunogenicity, that prescribers and the FDA have the ability to quickly and clearly trace the cause of any adverse reaction and—where a product-specific problem is identified—to alert other prescribers, pharmacists and patients using that product.”
And Biopharma-Reporter will be delving deeper into the issues affecting biosimilars with a free virtual event on September 26. Join four industry experts as they discuss the development, manufacture and sale of such products in a 60 minute seminar hosted by our Editor-in-Chief Gareth Macdonald. Click here for more details...