YourEncore Insights - Life Sciences

Considering Biosimilars – 3 Key Areas to Assess in Your Strategy

Posted by David Wierz on 10/13/16 9:22 AM

Innovators simply cannot afford to ignore biosimilars. These products have the potential to create significant clinical and financial advantages for both patients and payers.

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Topics: Biosimilars

Biosimilar Name Game:  The Brewing FTC & FDA Debate

Posted by Peter J. Pitts on 11/19/15 11:00 AM


There is an interesting (and potentially harmful) debate brewing between the FTC and the FDA on the naming of biosimilars. Should biosimilars have distinguishable names from their reference drugs?  

For the FDA’s part, the agency proposes the addition of a four-letter suffix to the nonproprietary name of all biologic medicines, including biosimilars. Such a distinguishable naming convention will promote both accurate prescribing and attribution of adverse events, the agency explained in a draft guidance.

The FTC, responding to the guidance, wants easy substitution of biosimilars for original biologic medicines and each other with price the “salient decision factor,” like it is for generic drugs. The FTC is concerned that distinguishable names would result in “physicians incorrectly (sic) believing” that biosimilars differ in clinically meaningful ways, leading to reduced price competition.

I think the physicians at the FDA, not economists at the FTC, are correct. Ironically, the FTC is concerned that distinguishable names will inhibit the uptake of biosimilars. On the contrary, distinguishable names will boost prescriber confidence and spur biosimilar use. Read my full article at The Morning Consult to hear why.

Authored By:

Peter J. Pitts. Executive Partner for YourEncore, President - Center for Medicines in the Public Interest, Former FDA Associate Commissioner.

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Topics: Pharmaceutical Industry, Regulatory, Biosimilars