Pfenex Statement in Response to Final FDA Guidance on Nonproprietary Naming of Biological Products

Pfenex supports the issuance by the FDA of final guidance for naming of biologic products as a demonstration of positive momentum in creating a regulatory framework for biosimilar products in the United States, however we note the exclusion of guidance for naming of interchangeable biologic products.

In order to facilitate the development of a robust biosimilars market and increase patient access, it is essential that the FDA and its regulatory counterparts demonstrate support for the safety of biosimilar products. While we are supportive of the FDA’s decision to move forward with a naming convention that includes a suffix devoid of meaning, we encourage the agency to consider the use of the International Nonproprietary Name (INN) for biosimilars determined to be interchangeable to a reference product, underscoring support for biosimilar use in the United States and reducing the potential of confusion for physicians and pharmacists.

As previously noted by the Federal Trade Commission (FTC), the use of proprietary names for interchangeable biologic products may lead stakeholders to believe such products have “clinically meaningful differences,” which by the very definition of a biosimilar is untrue. Such a naming convention for interchangeable products stands to increase confusion, hinder biosimilar uptake, and increase systemic costs.

As the US biosimilar market continues to evolve, it is imperative that regulatory agencies such as the FDA enact guidance that encourages stakeholder adoption and underscores biosimilar safety. We applaud the agency on the finalization of naming guidance and look forward to receiving final guidance from the FDA on interchangeability in the coming year.