ABP 501

ABP 501 is a biosimilar medication to adalimumab, which is used to treat various autoimmune diseases. It is marketed under the brand name Amjevita by Amgen. ABP 501 is designed to be highly similar to the reference product, adalimumab, with no clinically meaningful differences in terms of safety, purity, and potency.

Development and Approval

ABP 501 was developed by Amgen, a leading biotechnology company. The development process involved extensive comparative analytical, non-clinical, and clinical studies to demonstrate biosimilarity to adalimumab. The U.S. Food and Drug Administration (FDA) approved ABP 501 in September 2016, making it one of the first adalimumab biosimilars to receive FDA approval.

Mechanism of Action

ABP 501 works by inhibiting tumor necrosis factor (TNF), a substance in the body that causes inflammation in autoimmune diseases. By blocking TNF, ABP 501 helps reduce inflammation and other symptoms associated with conditions like rheumatoid arthritis, psoriasis, and Crohn's disease.

Indications

ABP 501 is indicated for the treatment of several autoimmune diseases, including:

• Rheumatoid arthritis
• Psoriatic arthritis
• Ankylosing spondylitis
• Crohn's disease
• Ulcerative colitis
• Plaque psoriasis

Administration

ABP 501 is administered via subcutaneous injection. The dosage and frequency of administration depend on the specific condition being treated and the patient's response to therapy.

Side Effects

Common side effects of ABP 501 include:

• Injection site reactions
• Upper respiratory infections
• Headache
• Rash

Serious side effects may include infections, malignancies, and hypersensitivity reactions. Patients are advised to discuss potential risks and benefits with their healthcare provider.

Related Pages

• Biosimilar
• Adalimumab
• Amgen
• Autoimmune disease
• Tumor necrosis factor