Some of the biggest biopharma companies in the business have offered some pointed suggestions to the FDA on how it should tighten up its regulations on biosimilar approvals. And some of their greatest concerns reflected some clear anxieties about the eventual arrival of cheaper competition.
For Novo Nordisk ($NVO), big in the diabetes arena, the prospect of having different delivery systems for biosimilars creates safety issues that the agency needs to guard against, according to in-PharmaTechnologist. And Novo outlined its call for more "robust" data than the FDA has spelled out in the proposed rules governing the field.
Amgen ($AMGN), which is the most vulnerable to looming competition, wants a clear and unambiguous demand for convincing clinical data in the biosimilar process. The FDA needs to "make clear that clinical studies will be necessary for the foreseeable future due to the complexity and diversity of human biology and the limits of scientific knowledge today," according to a report in PharmaTimes. And Amgen called for "class-specific guidance that discusses the approval standards and other key implementation issues for particular product classes" and "require all biological products to have a distinguishable nonproprietary name in order to facilitate accurate attribution of adverse events."
"There can be no grey area when it comes to patient safety," declared Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines, which includes Amgen, Genentech and BIO as members. "Unwanted immunogenicity is the preeminent safety challenge associated with biological therapeutics and can result in unexpected or sometimes severe adverse effects. The predictive value of animal studies is often insufficient to characterize immunogenicity in humans. Clinical studies, in addition to analytical methods, are necessary to weed out ineffective and unsafe drugs--innovator biologics and biosimilars--before they are ever a risk to patients."