Biosimilars: BIO Comments to Generic Pharmaceutical Association Citizen Petition Requesting the Food and Drug Administration to Implement its INN Naming Policy Equally to all Biologics

Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) respectfully submits these comments in response to the Generic Pharmaceutical Association (GPhA) Citizen Petition requesting the Food and Drug Administration (FDA) to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition).

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

The introduction of biosimilars into the marketplace raises novel and complex questions of science and law, and requires the updating of legal and regulatory frameworks to support overall public health and patient safety. BIO believes that a nonproprietary naming convention that ensures distinguishable product identification of all biological products best facilitates pharmacovigilance, ensures accurate attribution of adverse events to the right product, prevents inappropriate substitution and unintended switching, and supports tracing of products in the event of a recall; and thereby enhances patient safety. Accordingly, BIO respectfully requests that FDA deny the GPhA Petition.

Summary

For more than a decade, BIO has called for an open, transparent, and science-based dialogue regarding biosimilars. Many of our members are global leaders in the development and commercialization of biosimilars. BIO played a leading role in the effort to establish a statutory approval pathway for biosimilars. BIO supported the Biologics Price Competition and Innovation Act (BPCIA), which appropriately recognizesthat biosimilars are not generic drugs, and, accordingly, carefully calibrates the goal of increasing access to medicines at competitive prices with scientific considerations to ensure the development and approval of safe and effective biosimilar products within a system that instills prescriber and patient confidence. Leading scientific and regulatory authorities around the world have universally determined that treating biosimilars like generic drugs is inappropriate because biosimilars are similar to, but not the same as, their reference products.

Contrary to the GPhA Petition, we believe that a system that assigns the same name to products that are similar, but not the same, would create confusion for physicians and patients, hinder effective pharmacovigilance, and could jeopardize patient safety. We believe it is possible to craft a nonproprietary naming convention that both contributes to patient safety through enhanced product identification and improves access to medicines at competitive prices. Thus, BIO supports the development of a system under which nonproprietary names of biological products that are similar to each other in structure and function are distinguishable, but morphologically related, and which both prescribers and patients can easily recognize, remember, and report accurately. With appropriate education, such a system would introduce in the mind of the prescriber and patient not uncertainty – as alleged by GPhA – but rather the product identity and claritythat leads to greater prescribing confidence.