BPC Statement on FDA Draft Guidance entitled “Nonproprietary Naming of Biological Products”
August 27, 2015
WASHINGTON, Aug. 27, 2015 – Biosimilars are not generics and the Biologics Prescribers Collaborative (BPC) applauds the U.S. Food and Drug Administration (FDA) for recognizing that each biosimilar needs a distinguishable name in its draft guidance issued today. The FDA's draft guidance on nonproprietary naming of biological products proposes distinguishable names, calling for biological products to bear a nonproprietary name that includes an FDA-designated suffix. This proposal reflects the agency's thinking that "there is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable."
Those prescribers who work every day with biologics—and their patients—are the winners from FDA's decision. The agency recognized that distinguishable names are essential for pharmacovigilance, patient safety, and transparency.
BPC has strongly advocated for distinguishable names because it is consistent with the science, reflecting that no two biological products can be the same. As biosimilars come to market, it is crucial for physicians to recognize that while highly similar, there will be differences between a biosimilar and the originator product as well as among all biosimilars of the originator. Moreover, as FDA recognized, it is critical that physicians also understand that while a product may be approved as biosimilar, it does not mean it is interchangeable with the reference product, meaning that it has not been shown safe to switch back-and-forth between the two.
We appreciate the FDA's careful consideration of this important issue. Biosimilars hold tremendous promise to increase access to life-saving and life-enhancing biologic medicines for the millions of patients who rely on them. Today's decision by the FDA to clearly differentiate biosimilars from one another and the original biologic through distinguishable names will enhance transparency, help create physician confidence in biosimilars and support a robust biosimilar market.
As biosimilars continue to be evaluated by FDA, as well as further official agency guidances are issued, the BPC will continue to weigh in and to provide the critical perspective of biologics prescribers to ensure patient safety.
The Biologics Prescribers Collaborative is an organization of groups representing physicians who regularly prescribe biologics that aims to ensure that sound policies are in place to promote the safest possible use of all biologics, including biosimilars, for all patients.