Page 16 - 2017 V1 InsideOut

FDA Drops Long-Awaited Guidance on Biosimilars Interchangeability and Naming
by Stacie Heller
As President Obama prepared to leave of ce, the FDA in January released two much anticipated guidance documents required by the Affordable Care Act’s ab- breviated licensure pathway for biological products (pursuant to the Biologics Price Competition and Innovation Act, or BPCIA).
The rst guidance, “Considerations in Demonstrating Interchangeability With a Reference Product: Guidance for Industry,” (issued in draft form with comment period) outlines how companies can demonstrate interchangeability between biological products and branded coun- terparts. The draft guidance provides an overview of the scienti c evidence manu- facturers should consider for inclusion on the application to support interchange- ability, including:
» Data and information needed to support a demonstration of interchangeability
» Considerations for the design and analysis of a switching study or studies to support a demonstration of interchangeability
» Recommendations regarding the use of a US-licensed reference product in a switching study or studies
» Considerations for developing presenta- tions, container closure systems, and delivery device constituent parts for proposed interchangeable products
Companies are not required to submit an application for a proposed interchange- able product for all of the branded product’s approved conditions of use, though the guidance recommends it.
In a discussion of interchangeability, Leah Christl, Associate Director for Therapeutic
Biologics and lead of the Therapeutic Biologics and Biosimilars Staff in the Of ce of New Drugs, commented
how the data required to demonstrate interchangeability will be determined on a case-by-case basis and that “no single data package will work for all proposed interchangeable products.”
The FDA sought general comments (with a submission deadline of March 20, 2017) on the draft guidance and comments on how to regulate interchangeable products if there are manufacturing changes to an approved interchangeable product, or if there are changes to a branded product’s approved conditions of use after the inter- changeable counterpart is approved.
Biosimilars determined to be interchange- able can potentially change the as yet nascent U.S. biosimilar market (for addi- tional insight, see, "Are biosimilars the new generics?" for thoughts by industry expert Dave Pickard, published February 9, 2017 at beckershopsitalreview.com). Payers would have a stronger clinical argument for covering only the interchangeable, and pharmacists could potentially substitute an interchangeable for a prescribed biologic without consulting the ordering physician.
The FDA also issued nal guidance, “Nonproprietary Naming of Biological Products,” on the naming of biosimilars. Biosimilars and interchangeable biosimi- lars will share the same core name as their reference biologic; however, biosimilar product names will be hyphenated with a four-letter meaningless suf x: for example, INFLECTRATM (in iximab-dyyb).
Application of the new naming construct has prospective and retrospective components; all biologics (excluding in-
vitro reagents, blood grouping reagents, products whose names are assigned via regulation and cord blood products and blood components, among others) ap- proved after March 23, 2020, must follow the nal guidance’s naming convention. FDA’s guidance states the addition of the suf x is part of the FDA’s plan to improve pharmacovigilance for reference biolog- ics and their biosimilars. And, as such, all currently approved biologic products will be renamed.
The nal guidance was released to mixed reviews. While ASHP was generally supportive of adoption of a shared non- proprietary name for both biologics and biosimilars, the organization joined the industry at large in voicing concern about the retroactive application of the naming policy and the subsequent burden of changing existing systems to work with the new policy, noting the thousands of hours totaling billions of dollars on IT redesign and re-programming.
About the author
Stacie Heller, Vice President of Government Policy at AmerisourceBergen Corp., has more than 20 years experience tracking and analyzing regulatory policies affecting the healthcare industry. Stacie will be a regular contributor to Washington Update.
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