FDA Guidance on Biosimilar Naming Receives Mixed Response from Industry

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An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.

After finalizing its guidance on the nonproprietary naming of biosimilars on Jan. 12, 2017, FDA drew mixed responses from the industry. In the guidance, the agency finalized its decision to assign four-letter meaningless suffixes to new biosimilar products. FDA wrote in the guidance, “under this naming convention, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters.”

The Biosimilars Forum, a non-profit industry group focused on advancing biosimilars, said it was “disappointed” with FDA’s decision. In a written statement, the forum noted “non-meaningful suffixes will certainly be more difficult for physicians and patients to recall than meaningful suffixes,” the forum said. “Additionally, they will likely lessen the ability to carefully track the identity of the biologic drug administered to patients, thereby contrary to the stated purpose of having a suffix to enhance pharmacovigilance.”

Pfenex and the American College of Rheumatology (ACR) both came out in support of the decision. In a statement, ACR said it applauded FDA’s decision to assign distinct suffixes and that the move is critical to patient safety and prescriber confidence.

“The American College of Rheumatology has long advocated for explicit guidance about distinct names and suffixes for biosimilars in order to prevent inadvertent or inappropriate substitution, increase prescriber confidence and uptake of biosimilars, and ensure pharmacovigilence,” said Angus Worthing, MD, FACP, chair of the ACR’s Government Affairs Committee in a statement. “This is a welcomed step toward ensuring that biosimilars reach our patients as safely, transparently, and efficiently as possible.”

Pfenex said it supports FDA’s decision but noted the “exclusion of guidance for naming of interchangeable biologic products.” The company said it encourages FDA to consider the international nonproprietary name for any biosimilar product deemed to be interchangeable with its reference product.


“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,” the company said in a statement on its website.

Biosimilar naming conventions have been a hotly debated topic among industry groups and biopharma companies. Some industry groups support a suffix that identifies the manufacturer of the biosimilar. FDA has indicated that it does not want prescribers to judge the quality of a biosimilar based on its name. Additionally, FDA has said the naming protocol put in place by the agency is meant to prevent inadvertent substitution of biosimilars and reference products.

Source: FDA, Biosimilars Forum, Pfenex, ACR