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In 2023, adalimumab biosimilars took center stage in the biosimilar space due to 8 long-anticipated products finally launching.
After more than 6 years, the first adalimumab (Humira) biosimilar approved in the United States finally hit the market. The launch, as well as the subsequent 7 other adalimumab biosimilars that launched, were highly anticipated because of the high cost of Humira, making adalimumab biosimilars the hot topic in 2023 in the biosimilar space. Other top articles of the year included a look ahead at other autoimmune biosimilars and a report on the growing comfort and familiarity with biosimilars in the United States.
Here are the most-read biosimilars coverage of 2023, or you can read all of our coverage.
5. Gastroenterologists, Rheumatologists Cite Greatest Familiarity With Biosimilars
A report from Cardinal Health in February reviewed the potential impact biosimilars were expected to have in rheumatology, gastroenterology, dermatology, and ophthalmology. The report also analyzed data on biosimilar utilization, government pricing reform, and payer coverage. The survey of 350 providers found gastroenterologists were the most familiar with biosimilars (86% very familiar), followed by rheumatologists (76%). Ophthalmologists and dermatologists were much less familiar with only 33% and 31%, respectively, saying they were very familiar with biosimilars. Respondents also discussed what discounts they would want to see in order to be motivated to switch a patient to a biosimilar.
4. The Growing Wave of Biosimilars for Autoimmune Diseases
While 2023 was the year of adalimumab biosimilars, with 8 finally launching in the United States, there are more biosimilars to come in the autoimmune space. Adalimumab treats rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn disease, and ulcerative colitis. However, there are also biosimilars in development for ustekinumab (Stelara), etanercept (Enbrel), and tocilizumab. There are 2 etanercept biosimilars approved by the FDA, but due to patent litigation, neither will reach the market until 2029. On November 1, the FDA approved the first ustekinumab biosimilar, which was also granted interchangeability. Wezlana’s launch is also delayed due to a patent lawsuit and will not hit the market until 2025.
3. First Humira Biosimilar, Amjevita, Launches in the United States
It was a long road from approval to launch, but the first adalimumab biosimilar hit the US market on January 31, 2023. Amjevita from Amgen was first approved in 2016 but stayed off the market due to a settlement agreement with AbbVie, the maker of the reference product. The Amjevita deal gave the biosimilar 6 months of exclusivity before any other adalimumab biosimilars could launch. Amjevita launched with 2 pricing tiers: a 5% discount to the reference product’s list price, available after taking into account rebating and discounting practices, and a 55% discount available when those discounts and rebates are not taken advantage of.
2. AAM White Paper Offers Causes and Solutions to the US Generic Drug Shortage
In 2023, drug shortages were not uncommon. Over the summer, the Association for Accessible Medicines published a white paper offering solutions on how to handle the ongoing generic and biosimilar drug shortages. The paper pointed out the impact the business model and federal government policies have on generics and biosimilars, specifically that slow adoption rates for newer generics and biosimilars reduce the ability for companies to recoup investments and that Medicare reimbursements reward providers for prescribing the higher-cost products over generics and biosimilars.
1. Humira: The First $20 Billion Drug
The review of a House Oversight Committee investigation report on AbbVie’s practices pertaining to Humira was published in the February issue of The American Journal of Managed Care®. The committee had opened an investigation into AbbVie’s pricing and marketing practices in 2019 over concerns about government health program spending on the drug. The authors reviewed the reports and described policy debates around Humira, which was the highest-grossing drug, with worldwide revenues of $20.7 billion in 2021. They concluded that there needs to be efforts to shape regulatory landscapes to both promote competition and innovation.