Drugs

FDA, W.H.O. Have Like Biosim Naming Approaches: Attorney

Attorney Irena Royzman (Patterson Belknap) says that the World Health Organization (W.H.O.) final proposal for a worldwide biosimilar naming convention released 1/26 is similar to the FDA proposal that has drawn industry criticism. W.H.O. would add a “biologic qualifier” (BQ) suffix consisting of four random consonants and an optional two-digit checksum to the nonproprietary name of each biologic and biosimilar product. The FDA proposal also uses four random consonants as a suffix to nonproprietary names.

Writing in an online blog post, Royzman says that industry and healthcare stakeholder have criticized FDA for proposing to use random consonant suffixes rather than meaningful and thus memorable ones, citing concerns about a greater likelihood of reporting and prescription errors with meaningless names. The W.H.O. proposal is likely to draw similar criticism, she says.

Although the W.H.O. assigns an international nonproprietary name to each pharmaceutical substance, some national regulatory authorities don’t require them, according to Royzman. She says that Japan, for instance, requires a biosimilar to have the nonproprietary name of the reference product, plus “biosimilar” and a number indicating the order in which the biosimilar was approved in that country.

Royzman writes that the W.H.O. offered three reasons for rejecting meaningful biologic qualifiers. First, it expressed concern that such a system would make each BQ suffix effectively a proprietary item of the manufacturer associated with the product. Second, the W.H.O. was apprehensive that, through mergers and acquisitions, a company may come to manufacture a product with a BQ suffix that is associated with another company, causing confusion. And third, national regulatory authorities expressed a preference for meaningless, random identifiers.

“Public comments may persuade national regulators to revisit their preferences towards meaningless, random identifiers,” Royzman concludes. “If this occurs, the W.H.O. may also come to reconsider its rejection of meaningful BQs.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome