BRANDED DRUG MAKERS RAISE CONCERNS ABOUT BIOLOGICS

Representatives of the brand namepharmaceutical industry told Congressthat current pending legislation toaccelerate the marketing of generic"follow-on"biologics could create a"significant risk"for public safety "dueto the significant differences betweenbiologic products from different manufacturers."A key problem, according tothe Pharmaceutical Research andManufacturers of America (PhRMA), isthat "follow-on biologics are not identicalto innovator biologics."

PhRMA said that its members standready to support the establishment of aregulatory pathway for follow-on biologics,but only "if patient safety can beassured and the innovation of futuremedicines is not compromised."Althoughgeneric drug manufacturers arenot required to conduct clinical trials tosecure FDA marketing approval for theirregular "small-molecule"generic pharmaceuticals,such studies should berequired before generic biologics areapproved, PhRMA officials said.

Significantly, however, none of thepending bills addressing follow-on biologicswould require such testing. "Webelieve that unless clinical trials areconducted to show the safety andeffectiveness of follow-on biologics?patients would have no assurance thatthe product they are taking is safe,"PhRMA said.

The branded drug group also raisedconcerns that the pending legislation"would allow a follow-on biologic to bereplaced with a similar product—but aproduct with a potentially differentmakeup—at pharmacies, hospitals, andphysician offices. It is troubling to thinkthat physicians would not knowwhether their patients are receiving thespecific biologic treatment they prescribed,or a similar product that couldhave very different effects on thepatient,"PhRMA said.