Pfenex Statement in Response to FDA Proposed Naming Rule and Guidance for Biosimilars

Pfenex applauds the Food and Drug Administration (FDA) in providing for comment the proposed rule and guidance for the naming of biologics and biosimilar products. While we agree with the FDA that the assignment of a random four letter code to each biologic and biosimilar product could potentially “avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway”, it remains the position of Pfenex that biosimilars should be given the same International Nonproprietary Name (INN) as the reference biologic product both to achieve the articulated goal of the FDA, and to support the use of biosimilars in the United States, mimicking successful and safe naming conventions used for years in other geographies such as the EU. The additional suffix proposed will needlessly complicate the prescribing system and create confusion between physicians and pharmacists.

As the market for biosimilars continues to grow in the U.S., it is imperative that the FDA and other regulatory bodies enact rules to increase access to therapies such as biosimilars for patients. We thus urge the FDA to support a system of same INNs for biosimilars and the reference product to increase patient access, as well as encourage competition within the market, ensure patient safety and avoid confusion among providers and dispensers.