What Is the Value of the Interchangeability Designation for a Biosimilar?

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By Wayne Winegarden, Robert Popovian & Peter Pitts

Biosimilars, to date, have achieved the promise of reducing prices and drug spending in the United States. The unquestioned safety and efficacy of biosimilars have given providers, patients, and employers, amongst many others, the confidence that savings will be even more robust as we embark on the primary target: the launch of Humira (adalimumab) biosimilars. Humira is by far the all-time biopharmaceutical revenue generator, with more than $15 billion in US sales in 2021.[1]

Adalimumab biosimilars will also be the first biosimilars introduced in the retail marketplace. To date, the majority of biosimilar competition has been for provider-administered medicines. Providers administer such drugs at their offices or infusion centers. As such, there is no need to worry about interchangeability designations since the prescriber and the medicine dispenser is the same health care professional. However, since adalimumab biosimilars may be dispensed directly to patients who self-administer the medicine by a pharmacist, the interchangeability policy for a biosimilar requires further examination. As in the past, when patients, providers, and employers were misinformed about the interchangeability designation by some brand biologic manufacturers. Today, certain biosimilar manufacturers are trying to downgrade the value of having a biosimilar designated by the FDA as interchangeable.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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