Arthritis Treatment: Biosimilar Drugs for ... - Health and Fitness

Rheumatoid arthritis is the greatest in quantity common inflammatory form of arthritis and affects near two million Americans.

Until about seventeen years ago, the primitive treatment modalities available for rheumatoid arthritis allowed more control of disease but patients rarely went into perfect remission.

Biologic drugs- protein-based medicines that mark specific abnormalities in the immune system- revolutionized the usage of rheumatoid arthritis.

Their effectiveness has allowed rheumatologists to not sole control rheumatoid disease better but has smooth permitted many patients to achieve real remission.

Unfortunately, a major limiting agent has been the high price tag associated through these drugs with costs ranging anywhere from $1500 to $2200 per month.

The patents on a few of these drugs may be expiring shortly and some biotech and pharmaceutical companies are longing to develop biosimilar drugs. A biosimilar is not a generic medicine. It is defined by the FDA as a drug that is ?highly like or interchangeable with an already approved biologic medicine.?

Biologic compounds are very complicated. They are big molecule drugs. And that is why they vary from standard ?pills.? An pattern would be aspirin which is considered a little molecule drug. It measures 180 daltons and has 21 atoms. It has small ability to initiate an immune response and relics relatively stable over time.

In exhibition of differences, a typical monoclonal antibody biologic medicine measures 150,000 daltons, contains 20,000 atoms, degrades above time, and has the ability to generate a significant immune answer. Thus, the production of a biologic is an inherently unsteady situation requiring special handling and storage.

A biologic drug begins with a unique and proprietary small room line and goes through a number of complicated steps to create sure the end product is pure.

A company irksome to make a biosimilar has to start with the end produce and work backward. The sequence of amino acids that makes up the ?viscera? of an effective biologic medicine is what the manufacturer of a ?transcript? must produce.

The manufacturing process is likewise one that needs to adhere closely to that of the primitive drug. While not all steps are identical in this place, the important ones need to be.

Because of these differences, biosimilar drugs power of determination need to undergo clinical trial testing to make secure they function as well as the drug they are supposed to be ?copies? of.

According to the FDA, ?a biosimilar medicine is expected to produce the same clinical proceed in any given patient.?

Nathan Wei, MD, FACP, FACR is a rheumatologist and Superintendent of the Arthritis Treatment Center http://www.arthritistreatmentcenter.com/. He is a maker Clinical Assistant Professor of Medicine at the Seminary of learning of Maryland School of Medicine and consultant to the Public Institutes of Health. For more info: http://www.arthritis-usage-and-relief.com/arthritis-treatment.html

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