Dr Joseph Fuhr: Interchangeability Poses Too Much Risk, Too Little Reward

Joseph P. Fuhr, Jr, PhD, professor emeritus, Widener University, discusses interchangability in biosimilars.

Transcript (slightly modified)

How important is interchangeability for biosimilars?

Interchangeability is not important. There are 2 type of biologics: pharmacy, and physician-administered. In physician-administered, interchangeability will not matter, since the physician is picking the drug directly, so (there is) no need to substitute. In a pharmacy scenario, automatic substitution will occur, but are payers willing to pay a price premium for an interchangeable biologic?

Biosimilars are highly similar, so how much better is an interchangeable biologic? It is highly, highly similar, so if (the) copay is greater for (an) interchangeable, then will patients pay more for it?

Also, it costs more for an interchangeable study, since you need to do switching studies, which add to cost. So are firms willing to take on this investment with very little gain? There is 1-year exclusivity for interchangeables for each reference product, but other biosimilars will probably be in the market before this occurs.

Also, some believe they may not be able to apply without some post-market data—which will delay entry—and not be allowed to apply initially for interchangeability. Also, if they don’t get approved for interchangeability, will this hurt the image of (the) product and (its) market share? There’s too much risk for too little reward to go for interchangeability.