Fierce Biotech reports that surveyed physicians in the US say that they are/will be wary of prescribing biosimilars without clinical data to support similarlity to the reference drug. In particular, they will be very cautious in prescribing for another indication than the one for which the biosimilar data was developed, i.e. they will resist "indication extrapolation". Love that moniker -- kind of reminds me of "conjunction junction" as a child. But I digress. The Fierce data comes from an analysis done by Decision Resources.
This all implies that there will be a need for more clinical trials to generate data -- both for regulators and to convince physicians -- that will drive costs up and delay time to market. Again, this argues that only BIG companies with deep pockets will really be able to play in biosimilars while these conditions exist and persist.
This again makes me wonder if the strategy in the US ought to be aimed at developing biobetters as the regulatory and user community hurdles appear high. You may as well get paid for your efforts if you are going to have to do extensive trials anyway, right? On the other hand, Spain (and others) may just order physicians to prescribe the cheaper version.
Posted by Bruce Lehr Aug 25th 2011.