A Biosimilar Drug for Treating Rheumatoid Arthritis and Ankylosing Spondylitis Begins Phase 3 Trials

According to a story from Acrofan, the biotechnology company Clover Pharmaceuticals Inc. has recently announced that the first patient has been dosed in its phase 3 clinical study. This study is testing the company’s experimental biosimilar drug SCB-808. This drug is a biosimilar to the tumor necrosis factor (TNF) inhibitor etanercept (marketed as Enbrel), which is used as a treatment for rheumatic diseases such as ankylosing spondylitis and rheumatoid 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. 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. 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 Rheumatoid Arthritis

Rheumatoid arthritis is a chronic autoimmune disease that affects the joints. The joints of the wrists and hands are most frequently affected, and this most typically occurs on both sides of the body. Symptoms include warm, swollen, stiff, and painful joints. In more serious cases other body systems may be affected and can inflict symptoms such as rheumatoid nodules on the skin, vasculitis, lung fibrosis, anemia, and heart disease. Treatments may include medications to manage pain, rituximab, methotrexate, TNF inhibitors, and leflunomide. To learn more about rheumatoid arthritis, click here.

What Are Biosimilars?

Biosimilars are drugs that are extremely similar to a medication that has already been approved for use. These drugs must be tested under the same standards as original biologic medications. They are effectively a different version of the original reference drug and can legally be manufactured when the patent on the reference drug expires. They play a similar role to ‘generic’ drugs but often display a higher degree of complexity.

Improving Treatment for Rheumatoid Diseases in China

The testing is being conducted in China, and while there are other biosimilar for etanercept available in the country, SCB-808 is being developed in the more convenient pre-filled syringe formula, which will make it possible for patients to administer the drug themselves. In addition, this is the first biosimilar to be developed under the most recent biosimilar standards from the National Medical Products Administration, which requires that SCB-808 be compared in trials head-to-head versus etanercept. 

These differences should give SCB-808 an significant advantage if it gains approval.

 


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