Biosimilar Drug for Ankylosing Spondylitis gets Approved by the FDA

According to a story from Ankylosing Spondylitis News, the drug Hadlima, which is a biosimilar to the drug Humira (adalimumab), was recently approved by the US Food and Drug Administration (FDA) as a treatment for ankylosing spondylitis, a rare type of arthritis. The drug was also approved for a number of other diseases, including plaque psoriasis, ulcerative colitis, Crohn’s disease (in adults), rheumatoid arthritis, psoriatic arthritis, and juvenile idiopathic arthritis.

About Ankylosing Spondylitis

Ankylosing spondylitis is a rare form of arthritis which is characterized by long term inflammation of the spinal joints. Other joints may also be affected. The precise cause of ankylosing spondylitis has not been identified. A host of environmental and genetic factors may play a role; for example, a study found that the majority of patients in the UK presented with the HLA-B27 antigen. The onset of ankylosing spondylitis symptoms often begins in early adulthood. These symptoms may include relapsing/remitting back pain, progressive joint stiffening, fatigue, fever, and weight loss. Inflammation can spread to other parts of the body, such as the eyes, the cardiovascular system, and lungs. No cure for the disease exists, so treatment focuses on pain management and slowing disease progression. Treatment may include NSAIDs, opioids, TNF inhibitors, physical therapy, surgery, and some others. Unfortunately, most therapies can cause serious side effects with long term use. To learn more about ankylosing spondylitis, click here.

About Biosimilar Drugs

Biosimilars are drugs that are very nearly identical to another biologic drug that has already been approved. They are designed to provide the same therapeutic benefits and safety profile but are generally sold at a lower price than the name brand drug. Biosimilar drugs can be formulated and developed once the patent on the original drug expires.

Hadlima is a tumor necrosis factor (TNF) inhibitor; TNF is a protein that is involved in the inflammatory mechanism found in arthritic diseases. The approval of the biosimilar drug follows the results of a phase 3 clinical trial that demonstrated that Hadlima and Humira, the drug it is based on, displayed practically identical effects. The response rate for Hadlima and Humira was 72.4 percent and 72.2 percent respectively. Additionally, no adverse effects appeared when patients switched from Humira to Hadlima.


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