The definition of specialty drug varies which makes the 10 things to know about biosimilar drugs that much more relevant. In fact, the FDA does not define drugs as ‘Specialty’. The APhA (American Pharmacists Association) describes specialty medications as having some or all the following key characteristics:

• High cost (often more than $10,000 per patient per year)
• Special handling / Administration (refrigerate/frozen, drug delivery devices)
• Frequent dosing adjustments required
• Limited/Exclusive distribution by manufacturer
• Government required REMS (risk evaluation mitigation strategies) program
• Treats a complex/chronic condition that could lead to life threatening situations if left untreated
• Advanced patient training required in administration / usage of drug
• Biologics

Humira (adalimumab) is a biological drug that belongs to a class of medications called TNF inhibitors. It is used to treat a variety of autoimmune diseases, including rheumatoid arthritis, psoriasis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. Humira works by blocking the action of tumor necrosis factor-alpha (TNF-alpha), a protein that plays a role in inflammation. By reducing the activity of TNF-alpha, Humira helps to reduce inflammation and improve symptoms of autoimmune diseases.

Humira is administered as a subcutaneous injection and is typically given once every two weeks or once a week, depending on the condition being treated. The dosage and frequency of administration may be adjusted based on the patient’s response to treatment. Humira is one of the most widely used biological drugs, with sales of over $20 billion in 2020. It was first approved by the US Food and Drug Administration (FDA) in 2002 and has since been approved for use in over 100 countries.

While Humira is generally considered safe and effective, it can have side effects, including increased risk of infection, allergic reactions, and increased risk of certain types of cancer. Patients taking Humira should be closely monitored for side effects and should report any symptoms to their healthcare provider. Humira is also one of the most expensive drugs on the market, with an average cost of over $5,000 per month. However, the availability of biosimilar versions of Humira will help to reduce the cost of treatment for many patients. Here are 10 things to know about biosimilar drugs.

1. Biosimilars are biological drugs that are similar to a reference biological drug that has already been authorized for use.
2. Biosimilars are made using living cells and can be more complex than traditional chemical drugs, which are made from chemical compounds.
3. Biosimilars are not identical to the reference drug, but are highly similar in terms of quality, safety, and efficacy.
4. Biosimilars can be used to treat a variety of diseases, including cancer, autoimmune disorders, and chronic inflammatory conditions.
5. The development of biosimilars requires extensive testing and clinical trials to demonstrate that they are safe and effective.
6. Biosimilars are typically less expensive than the reference biological drug, which can help to reduce healthcare costs and increase access to treatment.
7. The approval process for biosimilars is different from traditional generic drugs and involves a detailed review of the manufacturing process and clinical trial data.
8. Biosimilars are regulated by the same agencies that oversee the approval of the reference biological drug, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
9. Biosimilars may have minor differences in their structure or composition compared to the reference drug, but these differences do not affect their safety or efficacy.
10. Biosimilars are becoming more widely used around the world, as more manufacturers seek to develop and market these drugs to meet the growing demand for affordable biologic therapies.

Amjevita (adalimumab-atto) is a biosimilar drug to Humira (adalimumab). It was approved by the US Food and Drug Administration (FDA) in 2016 for the treatment of several autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. Today, Amjevita is available in pharmacies at discounts as high as 55% off AWP.