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FDA Proposes Guidance, Rule on Biosimilar Naming

Drug vials

(angelsalamag054, Pixabay)

28 August 2015. The U.S. Food and Drug Administration proposed new guidance yesterday to provide a common, nonproprietary naming system for generic forms of biologic treatments, known as biosimilars. The agency also proposed a rule applying the system to six biologics and biosimilars already approved, announced with the guidance in a blog post on the FDA Web site.

As with generic drugs, biosimilars aim to provide branded-medication performance at a fraction of the cost, once the patent on a branded product expires. Unlike conventional generic medications that mimic the actions of chemical-based drugs, however, biosimilars need to demonstrate they are interchangeable with their branded counterparts. A provision of the 2010 Affordable Care Act creates an abbreviated regulatory pathway in the U.S. for biosimilars.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, and Karen Midthun, who directs the agency’s Center for Biologics Evaluation and Research, authored the blog post. The new guidance from FDA, released for comment yesterday, seeks to standardize the naming of biosimilars to prevent errors in substitution of biosimilars for the original biologics, and to make it easier to track and report safety issues with biosimilars.

The draft guidance covers nonproprietary names, also called proper names, of biologics that identify the products with other than the brand name given to the product. The agency proposes both the original biologic and biosimilar share a common reference name, with FDA assigning different and unique four-character suffixes for the original biologic and biosimilar. The suffixes, printed in lower-case roman characters, would be simple identifiers, with no inherent meaning.

The blog authors use an example to illustrate the naming system, with a fictitious biosimilar called by its nonproprietary  name replicamab. Under the system, FDA would assign the suffix “cznm” to the original biologic’s name, becoming replicamab-cznm. And the agency would assign “hixf” as the suffix to identify its biosimilar product, that becomes replicamab-hixf. Multiple biosimilars to the same original biologic would share the common reference name, but carry different suffixes.

FDA applies this identification system to a proposed rule, released for comment yesterday, assigning nonproprietary names to six biologics or biosimilars already approved by the agency. Those products are — using the proposed naming system — filgrastim-bflm, filgrastim-jcwp, filgrastim-vkzt, pegfilgrastim-ljfd, epoetin alfa-cgkn, infliximab-hjmt.

Reactions to the naming system from professional and industry groups are so far mixed. American College of Rheumatology that called for a system of this kind, says in a statement, “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved — pharmacists, providers and patients — which drug the patient is receiving.”

Biologics Prescribers Collaborative that also lobbied for this kind of system, calls it “consistent with the science, reflecting that no two biological products can be the same.” The organization adds, “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.”

Academy of Managed Care Pharmacy, however, disagrees with FDA’s approach. The organization, representing pharmacists in managed care organizations, recognizes the need for a naming system, but prefers keeping current conventions, such as those used to identify biologics in Europe. The group’s statement notes, “any departure from the currently accepted nonproprietary naming system will create confusion amongst health care practitioners and patients, have negative effects on the ability to ensure safe dispensing and tracking, and result in lower market adoption and cost-savings. ”

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