Wednesday, January 7, 2015

Biosimilars: A Time of Reckoning Has Arrived

Stanton R. Mehr, President, SM Health Communications LLC

On Wednesday January 8th, 2015, a Food and Drug Administration Advisory Committee unanimously recommended that the first agent to gain biosimilar status through the 351(k) pathway be approved. This has been a very long, slow road to reach a point that Europeans passed more than 7 years ago. Finally, however, the FDA is preparing to approve Sandoz’s version of filgrastim (brand name, Zarzio), and perhaps for all of the indications of Amgen’s innovator product, Neupogen. The FDA’s final decision is expected to be announced in March.

This move may finally open the door to other 351(k) applications and decisions, not only for filgrastim biosimilars but for epoetin, infliximab, adalimumab, and a number of other long-marketed biologics.

In announcing the decision, the health care community at large hopes that the FDA will finally go public with other associated and long-awaited determinations, which will have implications for biosimilar utilization, coding, and reimbursement.

Biosimilar naming conventions, indication extrapolation, and interchangeability designations are eagerly anticipated by the U.S. payer market. Market research tells us a great deal about how health plans, insurers, and pharmacy benefit managers will react to the potential choices each of these nuances present. Payers believe that FDA decision making in each area will significantly affect not only how quickly biosimilars are accepted onto drug formularies but how soon competitive forces may rise to lower biologic prices. For example, if the FDA judges a biosimilar to not be interchangeable with the innovator product, and also limits its approval to one indication rather than all four, this may force the manufacturer to offer large discounts to gain market access. In this situation, manufacturers trying to retain their marketshare may decide to similarly cut prices or add to rebates, to coax payers to prefer their biologic. This may compel payers to move from 4-tier formularies to 5-tier structures (i.e., from one specialty tier to preferred and nonpreferred specialty tiers).

The initial answers are finally right around the corner. We are all awaiting that green light. One thing is known: whichever way the FDA decides to go, we have a pretty good idea which way the payers will turn.  

SM Health Communications provides writing, consulting, and innovative market research services for the payer markets. Its proprietary P&T Insight™ virtual P&T Committee program is the leading mock P&T Committee product in the field. We’ve participated in many market research projects involving biosimilar development and launch, from the point of view of the biosimilar and the innovator drug manufacturer. For more information, please visit or contact Stanton R. Mehr, President, at

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