The top 5 most-read rheumatology stories of 2023 included the changing market dynamics in the adalimumab space, including new launches and interchangeability labels, as well as the addition of Stelara and Enbrel to the list of originators up for Medicare price negotiation.
The top 5 most-read rheumatology stories of 2023 included the changing market dynamics in the adalimumab space, including new launches and interchangeability labels, as well as the addition of Stelara (ustekinumab) and Enbrel (etanercept) to the list of originators up for Medicare price negotiation.
Here are the most-read rheumatology stories of 2023.
5. Abrilada Approved as Second Interchangeable Humira Biosimilar
Abrilada (adalimumab-afzb) received FDA interchangeability, becoming the fifth biosimilar with this designation. The approval allowed substitution without physician permission, improving patient access. Approved in November 2019, Abrilada was the final adalimumab biosimilar to launch in the United States. The FDA decision, based on the REFLECTIONS B538-12 study, ensured safety and efficacy in switching between Humira and Abrilada for rheumatoid arthritis. Pfizer executed a dual-price launch later that year, offering a low-concentration, citrate-free formulation. Multiple companies were pursuing interchangeability for their adalimumab biosimilars.
4. Stelara and Enbrel Chosen for IRA Price Negotiation
Stelara (ustekinumab) and Enbrel (etanercept), both originator medications anticipating biosimilar competition in the coming decade, were included in the initial list of 10 drugs selected for Medicare price negotiation under the Inflation Reduction Act (IRA). Signed into law by President Joe Biden in August 2022, the IRA mandated negotiations between Medicare Part D plans and pharmaceutical companies, with prices taking effect in 2026. Stelara and Enbrel, facing biosimilar competition, were chosen due to their high costs and lack of generic or biosimilar alternatives. The negotiation process, aimed at reducing drug costs, faced opposition from the pharmaceutical industry. The IRA also included provisions like insulin caps and prescription drug inflation rebates to impact medicine pricing.
3. Celltrion Launches Yuflyma on the US Market
Celltrion USA launched Yuflyma (adalimumab-aaty), one of the first biosimilars to Humira in the United States, following FDA approval in May 2023. Yuflyma is the fifth biosimilar from Celltrion USA to enter the US market and offers a patient-centric approach, aiming to increase access to high-quality biologics. The launch is part of a competitive landscape, with eight adalimumab biosimilars planned for July 2023. Yuflyma, a high-concentration, citrate-free adalimumab product, is approved for eight indications, and Celltrion USA has filed for an interchangeability designation.
2. CVS Predicts Interchangeability Won’t Drive Adalimumab Biosimilar Adoption
CVS Health's report challenged the significance of interchangeable designations for adalimumab biosimilars in driving adoption, contrasting with Cardinal Health's findings. The report offered insights into the introduction of adalimumab biosimilars referencing Humira in the United States, predicting factors that influenced adoption and formulary decisions. Eight adalimumab biosimilars entered the market in 2023 as of December 1, with CVS emphasizing competition as a key driver for cost reduction in autoimmune conditions, a leading expense for plan sponsors. The report cited Remicade (infliximab) market trends, indicating a 50% drop in average sales price after infliximab biosimilar introduction, supporting CVS's lowest net cost strategy.
1. Despite Steep Discounts, Humira Biosimilars Are Priced More Than Original Originator Price
A study indicated that despite significant Humira (adalimumab) discounts, certain adalimumab biosimilars launched at double the originator's price. This year, 9 FDA-approved biosimilars were projected for the United States, with 8 already introduced. Amgen's Amjevita used a dual pricing strategy (5% and 55% lower than Humira) for market entry. The analysis, the first of its kind, estimated net prices for payers post-rebates. From 2013 to 2020, Humira's list price increased by 141%, with pharmacy benefit manager rates rising. Medicaid rebates varied, affecting net prices. Interchangeable biosimilars may have enhanced market competition, but concentration and formulation specifics posed challenges.