Here are five things to know.
1. The guidance suggests different suffixes be added to the names of biologics and biosimilars. Since not all biosimilars are interchangeable with biologics, the suffixes aim to differentiate between biological products that are and are not fully substitutable, according to the report.
2. The Federal Trade Commission does not support the FDA’s proposal, arguing the suffixes could hurt the market for cheaper versions, reports The Hill.
“We believe this approach could result in a misperception among physicians that biosimilars differ in clinically meaningful ways from their reference biologics’ drug substances,” Tara Koslov, acting director of the FTC’s Office of Policy Planning, told The Hill Extra via email. “FTC staff remain concerned that this misperception could deter physicians from prescribing biosimilars, thus dampening biosimilar competition.”
3.Bruce Leicher, JD, general counsel and senior vice president for biosimilar maker Momenta Pharmaceuticals said assigning different suffixes for interchangeable drugs could suggest they are not the same, according to the report. In terms of implementation, the suffixes are mostly a data entry issue, as companies and providers would have to ensure the new suffixes are included in health databases and tracking systems.
“It does create confusion,” Mr. Leicher said, “But our position is we’re not sure it matters much.”
4. The World Health Organization expressed concern the guidance on suffixes may not align with international naming policies, affecting international efforts to synchronize drug names and develop unique identifiers for biologics, reports Bloomberg.
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5. On the other side, some brand name drugmakers and policy experts support the proposal, saying it’s necessary for biosimilars to be distinguished from biologics since they are not exact copies in the way generics are to brand name competitors, according to the report.
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