Biosimilars to Humira® (adalimumab) is a long-awaited and notable market event as they have the potential to improve affordability in the near- and long-term. 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 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.
We have anticipated a dynamic adalimumab landscape this year, with biosimilars likely to have positive impact on the competitive marketplace by driving down drug cost. Our teams have actively engaged on behalf of our clients to assess full and complete financial information for Amjevita. With the announcement of a low-cost (low wholesale acquisition cost) product, savings compared to Humira is possible. Navitus is adding this low-cost product to be included on formularies as of April 1, 2023. This is a first step toward long-term savings for clients and members. In addition, throughout 2023, Humira will remain on formulary to ensure benefit stability and minimal change for members currently on therapy.
greater competition can introduce greater affordability
Our teams will continue to monitor the situation as additional biosimilar market competition arrives this summer. As savings opportunity is identified, Navitus will assess adding other adalimumab biosimilar products to standard formularies. This is consistent with Navitus’ approach on other therapies; 15 biosimilars are on standard formularies as a result of cost improvements identified in associated financial reviews.
As these events unfold, our teams remain focused to enable savings with clinically appropriate, low-cost medication therapy options for prescribers, patients, plan sponsors and health plans alike.
WRITTEN BY BRENT EBERLE
As Senior Vice President, Chief Pharmacy Officer, Brent oversees Navitus’ health strategies division, which is responsible for clinical and population health initiatives, drug utilization review programs, formulary and rebate management, and specialty pharmacy operations.