The Sic et Non of Biosimilars

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  • 02/06/2014

Expectations for the FTC’s February 4th hearing on biosimilars were low and, by that measure, the meeting didn’t disappoint.

What was surprising was the degree of dissimulation and desperation portrayed by certain speakers. Also surprising (and not in a good way) was the unexpected naivety of the so many so-called “experts.” The term “dangerous idiots” comes to mind – not to put too fine a point on it. What was disappointing (but, alas, not surprising) was the one-sided nature of the presentations.

This really shouldn’t come as a surprise considering that the FTC’s excuse for holding this hearing was to focus on issues that might constrain competition. Unfortunately, too many of the presenters viewed safety and patient outcomes as a constraint to competition. Exactly zero FDA officials or physician organizations testified. Draw your own conclusions.

And, in a sort of twisted way safety and outcomes are a constraint to competition insofar as they have a direct impact on physician prescribing decisions. Nowhere was this more fiercely debated than in discussions of various examples of state legislation and the issue of biosimilar naming.

Let’s take each in turn.

On the state legislation front, more than a few speakers made the point that physician notification was anti-competitive because it somehow besmirches the reputation of generic drugs (and would do the same to biosimilars). Bruce Leicher (Senior Vice President & General Counsel for Momenta Pharmaceuticals) called physician notification a “tactic” to scare physicians. And Krystalyn Weaver (Director of Policy and State Relations, National Alliance of State Pharmacy Associations), pointed specifically at a Tennessee law that requires physician notification for pharmacy-based switching of epilepsy medications. She cited data that showed this requirement results in increased state spending for epilepsy medications (translation: increased physician insistence on innovator products). What she did not discus was the fact that epilepsy drugs fall into the category of Narrow Therapeutic Index medications.

If there had been an FDA speaker, there might have been appropriate comments about the FDA's Pharmaceutical Science and Clinical Pharmacology Advisory Committee that debated and determined that the bioequivalence specifications should be tightened for, among other categories, generic versions of epilepsy medications – and that FDA officials presenting at that adcomm signaled strong agency support for the move.

Anti-competitive or pro-patient? You be the judge.

Steven Miller (Senior Vice President & Chief Medical Officer, Express Scripts), said he had research showing that physicians don’t want information from pharmacists telling them which patients have filled a prescription – one of the key stumbling blocks to addressing the quagmire of adherence. (Miller was unable to cite the source of this data point.) Thus, according to Miller’s logic, physicians will not care to be notified about a pharmacy-level switch of an innovator biologic to a biosimilar (interchangeable or otherwise).

Well, there are a lot of things “physicians don’t want” – like having to adjust to the world of electronic health records – but that doesn’t mean things can’t (indeed must!) change.

It’s also important to mention that, in it’s 1979 report on generic drug substitution, the FTC concluded, “increased communication (as well as lower prices) may explain why most pharmacists report that product selection laws have had a positive effect on their relations with patients”

(Or as Sumant Ramachandra, Senior Vice President & Chief Scientific Officer, Hospira, commented, “Communications fosters confidence.”)

Anti-competitive or pro-patient? You be the judge.

As Geoffrey Eich (Executive Director, R&D Policy, Amgen) commented, “Hubris is for the uninitiated.”

Eich was one of the few voices for patient safety as a tool for competitiveness. He warned against “overly narrow or false choicesand asked:

* Must we choose between increased access or the ability to monitor specific medicines reliably?

* Must we choose between lower cost medicines or for patients to have a complete and accurate medical record?

* Must we choose between vigorous competition or enabling manufacturers to voluntarily stand accountable to the patients we serve?”

Why not transparently label biosimilars to engender patient and physician confidence?

Why not ensure accurate patient medical records that clearly identify specific products?

Why not select distinguishable non-proprietary names for distinguishable drug substances?

Increased access to biologic medicines can and should include policies appropriate for these classes of medicines. We believe in “and” not “or.”

Let’s be clear – an inability to identify specific biologic medicines reliably jeopardizes all biologic programs equally. Such a preventable lapse would constitute an inexcusable, unsustainable, anti-consumer approach to policy.

Momenta’s Leicher’s called out Eich’s comments as representative of the “campaign against biologics” being used to “scare” physicians away from biosimilars. Even though Amgen is going to be in the biosimilars business?

Leigh Purvis (Senior Strategic Policy Advisor, AARP) pointed to both state legislation requiring physician notification of biosimilars as well as differential naming systems as “roadblocks to competition.”

Does the AARP really believe that safety and, well, knowledge are roadblocks to competition?

Amgen’s Eich spoke to “and not or.” The philosophical father of this concept is the “sic et non” (“yes and no”) of the 12th Century theologian Pierre Abélard.  Abélard outlined rules for reconciling contradictions, the most important of which is noting the multiple significations of a single word.

In the case of biosimilars and the FTC, that word is “safety.”

Those who view physician notification and distinct naming as anti-competitive are addressing these issues through a single dimension.

And it just ain’t that simple.

As BioWorld Today reports,


In the end, the FDA will base its decision on what’s best for public health – not on commercial interests, Pitts said. “It isn’t a question of tactics or strategies trying to squash biosimilars in the womb,” he added, responding to some of the comments raised at the FTC workshop that suggested concerns about pharmacovigilance were simply an effort by brand companies to protect their market.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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