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Preferred Drug List (PDL) Status of Adalimumab (Humira®) and Biosimilars

Date: 01/27/25

Louisiana Healthcare Connections encourages current prescribers of Adalimumab (Humira®) for our members to consider writing a prescription for one of the biosimilar products for increased cost savings. Biosimilar drugs represent a clear opportunity to reduce healthcare costs while maintaining member access to vital therapies.

Biosimilars can be used in patients who have previously been treated with the reference product (treatment-experienced), as well as in patients who have not previously received the reference product (treatment-naïve).4

Effective January 1, 2025, the following adalimumab products are preferred* on the PDL Louisiana Medicaid Preferred Drug List (PDL):

Adalimumab Syringe Kit, Pen Kit (Humira®)

Brand Reference Product

Adalimumab-aaty Kit, Pen Kit (Yuflyma®)

Biosimilar

Adalimumab-adaz Kit, Pen Kit (Generic; Hyrimoz®)

Biosimilar

Adalimumab-adbm Kit, Pen Kit (Generic; Cyltezo®)

Biosimilar

*Clinical Authorization is still required for all drugs, both preferred and non-preferred in the Cytokine and CAM Antagonists PDL Class.

Clinical authorization requests for any adalimumab product can be submitted one of the following ways:

If you have any questions, please call Provider Services at 1-800-424-1664.

Thank you for your time and dedication to your patients,

Louisiana Healthcare Connections Pharmacy Department

Frequently Asked Questions:

What is a biosimilar?

The US Food and Drug Administration (FDA) defines a biosimilar as a “biological product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components.” “There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”1,2

Are biosimilars considered generic medications?

No. Biologics generally cannot be copied exactly because the products usually contain

a mix of many slight variations of a protein, and this mix is never exactly the same in each dose or batch of the product.4

How are biosimilars approved in the US?

The Biologics Price Competition and Innovation Act (BPCI Act) created an

abbreviated approval process for a biological product that is demonstrated to be biosimilar to a reference product.

Through this application process, the biosimilar product can rely on certain existing scientific knowledge about the safety, purity, and potency of the reference product to

support licensure.2,4

 

References:

  1. Daller J. Biosimilars: A consideration of the regulations in the United States and European Union. Regulatory Toxicology and Pharmacology. 2016 Apr;76:199-208. Doi: 10.1016/j.yrtph.2015.12.013.
  2. US Food and Drug Administration. Review and Approval. URL: https://www.fda.gov/drugs/biosimilars/review-and-approval
  3. US Food and Drug Administration. Biosimilar Product Information. URL: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
  4. US Food and Drug Administration. Overview for Health Care Professionals.URL: https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals