BPC praises FDA draft guidance on nonproprietary naming of biological products

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.