January 18, 2017
Authored and Edited by Thomas J. Sullivan; Linda A. Wadler
On January 17, 2017, FDA released a nonbinding draft Guidance for Industry, Considerations in Demonstrating Interchangeability with a Reference Product. The Guidance is intended to “assist sponsors in demonstrating that a proposed therapeutic protein product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement under the Public Health Service Act.” This is an important milestone in the Agency’s ongoing efforts in BPCIA’s implementation and is the first guidance to provide instruction on both the types of studies and data biosimilar product sponsors should submit to illustrate interchangeability with a reference biologic.
The period for submitting public comments on this draft Guidance closed on May 19, 2017, following an extension to allow interested parties additional time to submit comments. The majority of comments submitted praised the FDA for releasing this draft Guidance and agreed in part with the proposals. However, a number of industry practitioners expressed some criticism. An exemplary comment submitted by the Association for Accessible Medicines (AAM) and the Biosimilars Council called for the FDA to provide more detailed information on what characteristics the Agency will use to determine a product’s structural complexity, as a less complex product may only require a singular switching study to demonstrate interchangeability. AAM and the Biosimilars Council also requested additional clarity regarding FDA’s expectations for “fingerprint-like characterization” to support interchangeability, urged that pharmacokinetic and pharmacodynamic studies are not always clinically meaningful or reflective of clinically relevant immunogenicity, and requested that sponsors be able to use a non-licensed reference product in switching studies to support interchangeability, if an adequate bridge is established. They also argued that the “FDA does not have authority to require sponsors to conduct studies or submit data and information regarding uses for which they do not intend to seek an interchangeability determination.”
Vizient, Inc. similarly urged the FDA to allow the use of non-U.S.-licensed comparator products in switching studies to demonstrate interchangeability and requested clarification from the FDA regarding relevant structural and functional differences between the reference product and the proposed interchangeable product that the FDA believes are undetectable through current analytical capabilities. Vizient also recommended that interchangeable and biosimilar products be licensed for all applicable uses of the originator product, unless orphan exclusivity considerations exist.
A more in-depth analysis of the FDA’s draft Guidance can be found here. Notice of the Guidance can be found at 82 Fed. Reg. 5,579 (Jan. 18, 2017).
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