In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a response published in GaBI Journal.  The FDA comments echo language in the Administration’s FY2025 HHS Budget which alleges the interchangeable standard creates “confusion” among healthcare providers. On the contrary, Reilly explains, it creates confidence:   The interchangeable standard, through its additional data requirements, reassures physicians that switching won’t reduce treatment efficacy: 59% are more comfortable with an interchangeable being substituted at the pharmacy. “Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such. 50 U.S. state legislatures were not confused when they passed legislation limiting pharmacy substitution only to interchangeable biosimilars”, says Reilly. “These were supported by state medical societies conditional on these assurances. Breaking this commitment to physicians would be an unconscionable bait-and-switch by policymakers.”  Moreover, while the Administration claims eliminating the distinction would bring the U.S. more into line with European substitution practices, in fact the opposite is true:  The EMA does not weigh in on pharmacy substitution of biosimilars; this is reserved for member states and nearly every Western European country has decided (like U.S. states) that this is not acceptable. A 2019 survey revealed a strong majority (73%) of Europe’s physicians, like their U.S. counterparts, oppose third-party biosimilar substitution. Finally, biosimilar uptake is largely determined by insurer and PBM formulary design, not a biosimilar’s interchangeable designation, Reilly explains. “CVS Caremark, which controls 34% of the market, recently dropped the reference adalimumab in favor of its own co-branded biosimilar version. Within a week, adalimumab biosimilar market share rose from 5% to 36%, lack of automatic-substitutability by a pharmacist posed no obstacle”. Cigna, a PBM controlling 24% of the U.S. market, has announced plans to make a similar move in June. “The interchangeable biosimilar standard is working as intended: building physician confidence through data and providing a biosimilar option physicians can be certain will not jeopardize the treatment stability of a patient for whom maintaining it is a critical concern. There are several promising bipartisan legislative efforts underway in Congress bring more transparency to PBM formulary design and rebate practices. These represent a far more productive -and medically appropriate- target for reform efforts for those seeking to boost biosimilar uptake.”  Read the article in GaBI Journal here.

ASBM’s Michael Reilly: Preserve the US Interchangeable Standard that Has Helped Drive Physician and Patient Confidence in Biosimilars  In an April interview with EndpointsNews, an FDA official called on Congress to eliminate the distinction between biosimilars (which can be prescribed in place of their reference products by a physician) and “interchangeable” biosimilars, which can be substituted by pharmacists the way generics are. Doing so would undermine physician confidence in biosimilars and jeopardize treatment stability for many patients, according to ASBM’s Executive Director, Michael Reilly in a response published in GaBI Journal.  The FDA comments echo language in the Administration’s FY2025 HHS Budget which alleges the interchangeable standard creates “confusion” among healthcare providers. On the contrary, Reilly explains, it creates confidence:  The interchangeable standard, through its additional data requirements, reassures physicians that switching won’t reduce treatment efficacy: 59% are more comfortable with an interchangeable being substituted at the pharmacy. “Biosimilars, while safe and effective, aren’t generics and shouldn’t be treated as such. 50 U.S. state legislatures were not confused when they passed legislation limiting pharmacy substitution only to interchangeable biosimilars”, says Reilly. “These were supported by state medical societies conditional on these assurances. Breaking this commitment to physicians would be an unconscionable bait-and-switch by policymakers.” Moreover, while the Administration claims eliminating the distinction would bring the U.S. more into line with European substitution practices, in fact the opposite is true:  The EMA does not weigh in on pharmacy substitution of biosimilars; this is reserved for member states and nearly every Western European country has decided (like U.S. states) that this is not acceptable. A 2019 survey revealed a strong majority (73%) of Europe’s physicians, like their U.S. counterparts, oppose third-party biosimilar substitution. Finally, biosimilar uptake is largely determined by insurer and PBM formulary design, not a biosimilar’s interchangeable designation, Reilly explains. “CVS Caremark, which controls 34% of the market, recently dropped the reference adalimumab in favor of its own co-branded biosimilar version. Within a week, adalimumab biosimilar market share rose from 5% to 36%, lack of automatic-substitutability by a pharmacist posed no obstacle”. Cigna, a PBM controlling 24% of the U.S. market, has announced plans to make a similar move in June. “The interchangeable biosimilar standard is working as intended: building physician confidence through data and providing a biosimilar option physicians can be certain will not jeopardize the treatment stability of a patient for whom maintaining it is a critical concern.There are several promising bipartisan legislative efforts underway in Congress bring more transparency to PBM formulary design and rebate practices. These represent a far more productive -and medically appropriate- target for reform efforts for those seeking to boost biosimilar uptake.” Read the article in GaBI Journal here.