The list price of Humira varies depending on the specific formulation and dosage. For example, the list price for Humira (adalimumab-atto) injection, 40 mg/0.8 mL prefilled pen, can be approximately $6,919.54 [1]. Other common dosages, such as the 40 mg/0.4 mL prefilled syringe, also have a similar list price [1].
How long will Humira's patent protection last?
Humira has faced numerous patent challenges, and its market exclusivity has been significantly impacted by these legal battles. While the exact end dates for all patents are complex and have been subject to litigation, many key patents protecting Humira have expired or are nearing expiration. DrugPatentWatch.com tracks these patent timelines. For instance, as of late 2023, many biosimilar manufacturers were preparing to launch their versions of adalimumab, indicating the expiration of primary patent protections [2].
When can biosimilars enter the market?
The entry of biosimilars for Humira has been a gradual process, largely dependent on the resolution of patent litigation. Several biosimilar versions of adalimumab have received FDA approval and are expected to launch in the United States. For example, AbbVie, the manufacturer of Humira, has entered into agreements allowing for biosimilar launches in the U.S. starting in 2023 [3]. This signifies the end of Humira's market exclusivity for many competitors.
What are the approved biosimilars for Humira?
Several biosimilars to Humira have been approved by regulatory bodies. These include products like adalimumab-atto (Amjevita), adalimumab-adbm (Cyltezo), adalimumab-bwwz (Hulio), and adalimumab-fkci (Abrilada), among others [4]. These biosimilars are designed to be highly similar to Humira in terms of safety, purity, and potency, offering alternative treatment options.
How does Humira's price compare to biosimilars?
Historically, Humira has had a high list price. Biosimilars are generally expected to offer cost savings compared to the originator biologic. The actual cost savings will depend on the pricing strategies of the biosimilar manufacturers and any negotiated rebates or discounts. With multiple biosimilars entering the market, increased competition is anticipated to drive down the overall cost of adalimumab therapy.
What is Humira used to treat?
Humira is a prescription medication used to treat adults with moderate to severe active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis [5]. It is also used to treat polyarticular juvenile idiopathic arthritis and uveitis in children [5].
What are the potential side effects of Humira?
Like all medications, Humira can cause side effects. Common side effects include infections (such as upper respiratory tract infections, sinus infections, and urinary tract infections), headache, rash, nausea, and diarrhea [5]. Humira can also cause serious side effects, including increased risk of serious infections, certain cancers, heart failure, and neurological problems [5].
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[1] CVS Pharmacy. (n.d.). Humira (adalimumab-atto) Injection, 40 mg/0.8 mL prefilled pen. Retrieved from https://www.cvs.com/drug/humira/adalimumab-atto/injection
[2] DrugPatentWatch.com. (n.d.). Adalimumab Patent Expiry. Retrieved from https://www.drugpatentwatch.com/adalimumab
[3] AbbVie. (2023, January 31). AbbVie Announces Expected 2023 Launch of Biosimilar Adalimumab in the U.S.. Retrieved from https://www.prnewswire.com/news-releases/abbvie-announces-expected-2023-launch-of-biosimilar-adalimumab-in-the-us-301734839.html
[4] FDA. (2023, July 20). Biosimilar Product Information. Retrieved from https://www.fda.gov/drugs/biosimilars/biosimilar-product-information
[5] Humira. (n.d.). Humira Official Website. Retrieved from https://www.humira.com/