Last month, staff of the Federal Trade Commission ("FTC") submitted a comment to FDA addressing the latter's draft guidance on the nonproprietary naming of biological products. Under the recently issued draft guidance, FDA proposes that a unique, FDA-designated suffix be added to the nonproprietary name of each biological product, including biosimilars. The FTC staff's comment expresses concern that this draft guidance may hinder competition and recommends that FDA consider alternative policies. Specifically, the comment asserts that physicians may mistakenly interpret the different suffixes as indicative of meaningful clinical differences and that such perceived product differentiation would have a dampening effect on price competition between brand products and biosimiliars. The comment cites an example from Europe, where biosimilars with distinct nonproprietary names from their reference biologic experienced less market penetration relative to biosimilars with the same nonproprietary name as the brand product.
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