What is Hadlima and How Does It Work?
Hadlima is an adalimumab biosimilar, meaning it is a biologic drug highly similar to an existing FDA-approved reference product, Humira. It is a tumor necrosis factor (TNF) blocker, which is a class of medicine that works by suppressing the activity of TNF-alpha. TNF-alpha is a naturally occurring protein in the body that can cause inflammation, and in autoimmune conditions, it is produced in excessive amounts. By binding to and blocking TNF-alpha, Hadlima reduces inflammation, thereby alleviating symptoms and preventing further tissue damage.
Broad Spectrum of Treatment for Inflammatory Conditions
One of the most significant benefits of Hadlima is its wide range of indications for various autoimmune and inflammatory diseases. It is approved by the FDA to treat moderate to severe conditions in adults and pediatric patients where other therapies may be less suitable.
Rheumatoid Arthritis (RA)
Hadlima helps reduce pain, swelling, and stiffness in adults with moderately to severely active RA. It can be used alone or with methotrexate and has shown effectiveness in inhibiting structural joint damage and improving physical function.
Juvenile Idiopathic Arthritis (JIA)
For pediatric patients aged two years and older with moderately to severely active polyarticular JIA, Hadlima provides relief from signs and symptoms.
Psoriatic Arthritis (PsA)
Adults with active PsA can benefit from Hadlima's ability to reduce joint pain, swelling, and skin lesions associated with psoriasis. It also helps slow joint damage progression and improve physical function.
Ankylosing Spondylitis (AS)
Hadlima can significantly reduce signs and symptoms in adult patients with active AS, improving mobility and quality of life.
Crohn's Disease and Ulcerative Colitis (IBD)
In adults and pediatric patients over 6 years old with moderately to severely active Crohn's disease and ulcerative colitis, Hadlima helps induce and maintain clinical remission. It reduces gut inflammation and improves outcomes for those who haven't responded well to other treatments.
Plaque Psoriasis (Ps)
Adults with moderate to severe chronic plaque psoriasis may see significant improvement in skin lesions with Hadlima, especially when other systemic therapies are not suitable.
Hidradenitis Suppurativa (HS) and Uveitis
Hadlima is also approved for treating moderate to severe HS in adults and non-infectious uveitis in adults.
Advantages of Choosing an Interchangeable Biosimilar
Hadlima's status as an interchangeable biosimilar provides benefits beyond its therapeutic effects.
Potential Cost Savings
Biosimilars like Hadlima can increase market competition, potentially lowering out-of-pocket costs for patients. Studies have indicated that patients may pay less out-of-pocket for Hadlima compared to Humira.
Interchangeability Designation
Hadlima's FDA interchangeability designation allows pharmacists in many states to substitute it for Humira without requiring prescriber approval. This simplifies access to a potentially lower-cost option.
Consistency and Quality
Hadlima has shown no clinically meaningful differences in safety, purity, or potency compared to Humira, ensuring a high standard of care and therapeutic effect.
Hadlima vs. Humira Comparison
| Feature | Hadlima (adalimumab-bwwd) | Humira (adalimumab) |
|---|---|---|
| Drug Type | Interchangeable Biosimilar | Reference Biologic |
| Mechanism of Action | TNF-alpha blocker | TNF-alpha blocker |
| FDA-Approved Indications | Same as Humira | Same as Hadlima |
| Comparative Efficacy | Clinically comparable | Clinically comparable |
| Cost | Generally lower out-of-pocket costs | Generally higher out-of-pocket costs |
| Substitution | Pharmacists can substitute for Humira without prescriber approval in many states | Not applicable |
| Administration | Subcutaneous injection via autoinjector or prefilled syringe | Subcutaneous injection via autoinjector, syringe, or vial |
Conclusion
Hadlima is a valuable treatment option for managing chronic inflammatory diseases due to its efficacy and potential cost savings as an interchangeable biosimilar to Humira. It has demonstrated comparable safety and effectiveness. Additional information about Hadlima's benefits can be found on {Link: Drugs.com https://www.drugs.com/compare/hadlima-vs-humira}.
