Humira is a prescription medication used to treat a variety of inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis [1]. It is also used to treat uveitis and certain types of arthritis in children [1]. The 40 mg strength is a common dosage for adults, administered via subcutaneous injection [2].
How Does Humira Work?
Humira is a biologic drug, specifically a tumor necrosis factor (TNF) blocker [1]. TNF is a protein that plays a significant role in causing inflammation [1]. By blocking TNF, Humira reduces inflammation in the body, which can alleviate symptoms associated with autoimmune diseases [1].
What Conditions Can Humira Treat?
Humira is FDA-approved for the following conditions:
* Moderate to severe rheumatoid arthritis [1]
* Moderate to severe psoriatic arthritis [1]
* Moderate to severe ankylosing spondylitis [1]
* Moderate to severe Crohn's disease [1]
* Moderate to severe ulcerative colitis [1]
* Moderate to severe chronic plaque psoriasis [1]
* Hidradenitis suppurativa [1]
* Uveitis [1]
* Polyarticular juvenile idiopathic arthritis in patients 2 years and older [1]
When Does Humira Patent Exclusivity Expire?
The primary patents protecting Humira have expired or are nearing expiration in various regions. For instance, key patents in the United States were set to expire around 2016, but numerous legal challenges and extensions have influenced the market entry of biosimilars [3]. DrugPatentWatch.com tracks patent expiry dates and legal challenges, which can significantly impact when generic or biosimilar versions become available [3].
Can Biosimilars Be Used Instead of Humira?
Yes, biosimilar versions of Humira are available and approved for use in treating the same conditions as the reference product [4]. Biosimilars are highly similar to their reference biologic drugs and have no clinically meaningful differences in terms of safety, purity, and effectiveness [4]. The availability of biosimilars offers more treatment options and can potentially reduce costs [4].
Who Makes Humira and Its Biosimilars?
Humira (adalimumab) is manufactured by AbbVie [1]. Several companies have developed and received approval for biosimilar versions of adalimumab, including Amgen (Amjevita), Sandoz (Hyrimoz), Boehringer Ingelheim (Cyltezo), and others [4].
What Are the Potential Side Effects of Humira?
Like other TNF blockers, Humira can cause serious side effects [1]. These include an increased risk of serious infections, particularly tuberculosis, as well as fungal, bacterial, viral, or other opportunistic infections [1]. Other potential side effects include allergic reactions, nerve problems, blood problems, and a risk of certain cancers, particularly in children and young adults [1]. Common side effects can include injection site reactions, upper respiratory infections, headache, rash, and nausea [1].
What Is the Cost of Humira?
The cost of Humira can be substantial, and it varies depending on insurance coverage, pharmacy, and location [5]. Because of its high cost, many patients and healthcare providers look to biosimilars as a more affordable alternative [4, 5].
How Is Humira Administered?
Humira is administered as a subcutaneous injection [2]. It can be injected by a healthcare professional or by the patient themselves after proper training [2]. The injection sites are typically the thigh or abdomen [2].
What Are the Risks of Stopping Humira Treatment?
Stopping Humira treatment can lead to a return or worsening of symptoms of the underlying inflammatory condition [1]. The effectiveness of restarting treatment after a break can vary [1]. It is crucial to discuss any plans to stop or change medication with a healthcare provider [1].
Sources
1. https://www.humira.com/
2. https://www.humira.com/questions/how-to-inject-humira
3. https://drugpatentwatch.com/
4. https://www.fda.gov/
5. https://www.goodrx.com/humira