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Biosimilars: Pharma resurrects a new “Narrow Therapeutic Index Strategy”

January 31, 2013 

Andrew Pollack’s article in yesterday’s New York Times about Biosimilars reminded me that some things never change-they just get reinvented.

As big Biotech rushes legislation to statehouses to limit therapeutic substitution of Biosimilars, it reminded me of the many battles between generic manufacturers and pharma with drugs like warfarin and cyclosporine, so-called NTI drugs because  of the risk that fluctuations in the concentration of these drugs in the bloodstream pose. Generic manufacturers and pharma are well versed in these strategies and their outcomes.  As the article points out, what’s different this time is that this game will not be played in retail pharmacies but in specialty pharmacies-where payers will be driving the decision to substitute. This battle seems to be much ado about nothing, even for injectable drugs dispensed through retail, as this issue will largely become a payer contracting issue involving a “step-edit” that pharma will have to pay insurers to remove.

It will be interesting to see if the same pattern of pricing reductions that follow the introduction of multiple generics will repeat itself as Biosimilars crowd many categories of expensive mABs, especially given the cost to manufacture these generic Biologics.

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