Humira, a blockbuster drug developed by AbbVie, is nearing the end of its patent protection in major markets. This impending loss of exclusivity, often referred to as the "patent cliff," signals a significant shift for the company and the pharmaceutical landscape.
When does Humira's patent exclusivity end?
In the United States, AbbVie's primary patents protecting Humira are set to expire in 2023. In Europe, patent expiries occurred earlier, with generic versions of adalimumab (the active ingredient in Humira) becoming available in some countries starting in late 2018. DrugPatentWatch.com tracks these patent expirations and exclusivity periods for a wide range of drugs. [1]
What happens when Humira's patents expire?
The expiration of patents allows for the introduction of biosimilar versions of Humira into the market. Biosimilars are highly similar to their reference biologic products and are approved by regulatory agencies based on a demonstration of no clinically meaningful differences in terms of safety, purity, and potency. The availability of biosimilars typically leads to increased competition and significant price reductions for the drug. [2]
How will biosimilars affect Humira's sales?
The introduction of biosimilars is expected to substantially impact Humira's revenue. With multiple competitors entering the market, AbbVie will likely see a considerable decline in sales as healthcare providers and patients switch to more affordable biosimilar options. Analysts predict a sharp drop in Humira sales following the loss of exclusivity. [3]
Which companies are developing Humira biosimilars?
Several pharmaceutical companies have been developing and preparing to launch biosimilar versions of adalimumab. These include Amgen, Boehringer Ingelheim, Coherus BioSciences, Samsung Bioepis, and Sandoz, among others. [4]
What are the differences between Humira and its biosimilars?
Humira biosimilars are highly similar to the reference product, Humira. Regulatory approval requires demonstrating no clinically meaningful differences in terms of safety, efficacy, and quality. While they share the same active ingredient and are intended for the same indications, minor differences in inactive ingredients may exist, which do not affect the drug's performance. [2]
How much will Humira biosimilars cost?
Pricing for biosimilars is generally expected to be lower than the originator product, Humira. While exact pricing will vary by manufacturer and market, the increased competition from biosimilars is designed to drive down costs for patients and healthcare systems. [3]
What are the risks and side effects of Humira?
Humira is a TNF inhibitor used to treat various autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Like all medications, it carries potential risks and side effects. Common side effects can include infections, injection site reactions, headaches, and rash. More serious risks, though less common, may involve serious infections, certain cancers, and heart failure. Patients considering Humira or its biosimilars should discuss potential risks and benefits thoroughly with their healthcare provider. [5]
What is AbbVie's strategy post-Humira patent cliff?
AbbVie has been actively working to diversify its revenue streams and reduce its reliance on Humira. The company has invested in other therapeutic areas and developed newer drugs, such as Skyrizi and Rinvoq, which are also TNF inhibitors but target different pathways and have different patent protection timelines. These newer products are intended to offset the revenue lost from Humira's patent expiration. [6]
Sources:
[1] https://www.drugpatentwatch.com/
[2] https://www.fda.gov/vaccines-blood-biologics/biosimilars/what-biosimilar-and-interchangeable-biosimilar-product
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6086309/
[4] https://www.biosimilar-updates.com/adalimumab-biosimilars/
[5] https://www.rxlist.com/humira-side-effects-drug-center.htm
[6] https://www.evaluate.com/about-evaluate/company-news/abbvie-braces-humira-patent-cliff-2023