Generic Biologics on the Horizon for Rhumatoid Arthritis Sufferers
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Generic Biologics on the Horizon for Rhumatoid Arthritis Sufferers

Information regarding biologic drugs that will soon be available for sufferers of rhumatoid arthritis.

According to the main article in the arthritis publication; "RA Today" by Anne Wainscott-Sargent, within the next few years, the estimated 1.3 million adult Americans with RA (rhumatoid arthritis) may have more and greatly less expensive choices for anti-inflammatory drugs. More than thrity branded biologics with sales over fifty billion dollars are scheduled to go off patent between 2011 through 2015. The new breed are biosimilars and are projected to grow to $3.7 billion by 2015.

Biologic agents, or more familiarly biologics are drugs produced by living cells and more difficult to produce due to their complex nature than regular generic drugs. The United States Food and Drug Administration (FDA) will be revamping their regulations for these new generic drugs that must comply with the Biologics Price Competition and Innovation Act (BPCI). This legislation was approved as part of the Affordable Care Act (ACA) of 2010.

The Arthritis Foundation and its Vice Presidence of Advocacy, Amy Melnick is concerned because without the regulatory pathway, manufacturers would have no guidelines to proceed with developing these types of generic drugs. According to Melnick, the concern is both with price of these drugs and their efficacy, but without regulations, it is a hit and miss process. As for the financial savings, it has yet to be determined.

The main concern for the Arthritis Foundation is to be sure that these new generic drugs work and Melnick went on the "strongly recommend" that the FDA must require clinical evidence that people with active rhumatoid arthritis should be put into clinical trials prior to release of these biosimilar drugs.

The Biotechnology Industry Organization (BIO), a biotech trade organization with members from the healthcare research and development sector, support the FDA's role in the approval of biosimilars provided that there are evaluation measures in place.

Another prime concern of the Arthritis Foundation is the safety of these biologic drugs. Will they be clearly labled? If they take a drug and have a terrible side effect; will the label state when it was manufactured and the lot that it came from? Doctors have to know that the drug their patients are taking is one they can trust.

As for the cost of insurance, it was recently reported in "Arthritis Today" that out-of-pocket expenses for arthritis medications is rising faster than for many other chronic diseases. From 1998 to 2004 the cost increased 7.3 percent per year compared with diabetes drugs that only increased 5.8 percent over the same period.  They cited one RA sufferer who had to discontinue her medication for Embrel when it topped $1000 per month and stated that; "RA is a disease only for the wealthy."

"RA Today" and "The Arthritis Foundation" are dedicated to the health of the people who have Rhumatoid Arthritis and provide a list of drug assistance programs for sufferers of this debilitating disease.

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Comments (2)

Great one to vote up!

I know several people with RA and they tell stories like this--the high cost of prescriptions, etc. Very sad that drug companies take advantage of the sick and poor.