States Debate Rules for Biosimilar Swaps

February 12, 2015

by Amanda Conschafter, blog editor

First filgrastim, now infliximab. With the FDA’s announced date for considering a second imitation biologic, the agency inches still closer to approving the United States’ first biosimilar drugs. And the move prompts states to consider a crucial patient safety question: Will physicians know when pharmacists switch a prescribed biologic for a similar-but-not-identical biosimilar?

The issue hinges on the slight variations between brand-name biologics and their follow-on biosimilars. The FDA will require approved biosimilars to prove sufficiently similar (“therapeutically interchangeable”). But the two medications will not be identical in the way that traditional, synthetic medicines and their generic counterparts are. So while biosimilars may prove safe and effective for many patients, some may elicit different responses. Physicians argue that they need accurate data on which medication their patients receive so they can monitor the drugs’ effects.

Several states have taken this patient safety measure to heart. Oklahoma, Georgia, Texas, Oregon, New Jersey and others have current bills that require pharmacists to communicate with physicians about biosimilar switches – and to keep accurate records of these switches. Several bills also reinforce a physician’s right to require “dispense as written,” ensuring that a patient receives the exact medication prescribed.

The issue also introduces patient safety ramifications, as biologics can affect patients’ immune systems. As biosimilars enter the market, physicians will be watching to see which biosimilars also produce immunogenic affects, at which doses and for which patient populations. Precise knowledge of the medication a patient takes can allow physicians to track these response.

State debates about physician communication and biosimilar substitution are likely to continue into the coming months, as biosimilars move nearer to presenting lower-cost options for patients.

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