Humira Biosimilars Enter the Marketplace – Update on Navitus’ Review

The market entry of biosimilars to Humira^® (adalimumab) is long-awaited. These products have the potential to improve affordability in the near- and long-term for patients, plan sponsors, and health plans. Navitus is committed to making medications more affordable for the people who need them and uses established clinical and financial review processes to determine inclusions in standard formularies.

This update provides insight into our decision on the first Humira biosimilar, Amjevita.

The first biosimilar to Humira, Amgen’s Amjevita, launched February 1, 2023. This is the first of many biosimilar products expected to enter the market this year with potential to drive greater affordability of adalimumab therapy for inflammatory conditions.

What is a biosimilar?

The FDA defines a biosimilar as a biological product that is highly similar to an FDA-approved biologic (known as the reference product) and used in the prevention or treatment of disease. While not chemically identical, a biosimilar has no clinically meaningful difference from a reference product. It is FDA-approved for use after rigorous evaluation and testing is demonstrated by the manufacturer applicant.

Biosimilars are not generics

Generic drugs are chemically identical to their reference product. Because biosimilars are made from living organisms, they don’t contain identical ingredients. Therefore, stringent testing and demonstration is required for approval.

NAVITUS' REVIEW

We have anticipated a dynamic adalimumab landscape this year, with biosimilars likely to have positive impact in the marketplace by driving down drug cost. Navitus’ assessment of Amjevita determined that a similar net price was seen between both the high-cost/high-rebate product and the low-cost/low rebate product.

Decision Philosophy

Updated April 4th, 2023

As the market reacted to this first Humira biosimilar, it has been a popular choice of PBMs to include the high-cost/high-rebate product. 

Because Navitus operates as a full pass-through pharmacy benefit manager, there is no incentive to create spread by preferring a high-cost/ high rebate product when net costs are the same. Our focus is on what offers the most benefit to clients and members. Currently, that is the low-cost Amjevita product, considering the following:

• The low wholesale acquisition cost supports lower upfront drug costs for plan sponsors. This is compared to spending more now and awaiting a rebate several months later.
• The low-cost product reduces out-of-pocket expenses for members enrolled in high-deductible health plans and offers stability for members on-therapy. Should a future decision be made to prefer other adalimumab biosimilar(s), the low-cost product helps to maintain affordability until a member's transition to an alternative preferred product. 

Our teams will continue to monitor the evolving landscape as additional biosimilar competition arrives this summer.