If you live with rheumatoid arthritis (RA), there’s a good chance that your doctor has talked to you about Biologics. For many, this class of drugs have been a lifesaver, helping them to achieve remission or such low disease activity that they are able to live a largely normal life. Many others have not responded to the Biologics currently on the market or may not be able to afford the up to $30,000 a year cost of these drugs. This may soon change, as biosimilars begins to be approved for use.
What are biosimilars?
Most types of medications are available in two types: the brand name and the generic version. When a pharmaceutical company develops a drug, they have patent protection on it for a certain number of years. After that, other companies are allowed to develop a generic version. Generic medication is chemically identical to the brand name drug and is made in the same dosages, has the same safety, strength, method of administration, and use. Although identical to the brand name, generic drugs tend to be much cheaper and therefore are used more widely.
For the past 16 years, Biologics have been manufactured under patent protection. For many of the Biologics, this protection will end in the next few years, leaving the door open for the development of cheaper versions.
Biologics are created from living organisms, rather than chemicals, and the molecules involved are large and quite delicate. The complexities involved in manufacturing Biologics make them virtually impossible to copy. This means that we will not see generic versions of Biologics. Instead, companies are working on creating biosimilars.
Biosimilars are not identical to a biologic drug, but rather a "copycat." There are two types of classifications from the FDA. One, the biosimilar, is highly similar to a biologic drug. The other classification is "interchangeable," which, although it may include "allowable differences," will meet the biosimilar standard and second, be shown to have the same clinical results and will work in the same way as a particular biologic medication. That means that in order to receive interchangeable status, a biosimilar will be required to go through a special evaluation process that includes both animal studies and clinical trials.
Currently, a number of biosimilars are being developed for RA treatment. Some have been approved for use in Europe, Russia, and India.
Hope and risk
Biosimilars present a great deal of hope for people who live with inflammatory arthritis. Because they are not identical to Biologics, they represent a treatment which may work slightly differently from the biologic. Biosimilars therefore add to the treatment options available. As well, the reduced price estimated at a 30-40 percent saving can make this treatment accessible to more people, and saving the health care system a significant amount of money.
However, any discussion of biosimilars also includes a discussion of the challenges and potential risks. The small variations may impact the drug efficacy and safety. Standards for approval have yet to be established by the FDA. Because of this, the American Autoimmune and Related Diseases Association issued a statement expressing concern about this lack of standards and calling for clarity and transparency.
Biologics are complex medications. The issue of creating more accessible and cost-effective variants of these medications is equally complex. Much care needs to be taken in the approach to standards and approval of biosimilars, as well as the use of these new medications. At the end of the day, however, they represent new options that have the potential for helping many more people live better lives with RA.
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Lene writes the award-winning blog The Seated View. She’s the author of Your Life with Rheumatoid Arthritis: Tools for Managing Treatment, Side Effects and Pain and 7 Facets: A Meditation on Pain
Lene Andersen is the Community Leader for HealthCentral’s RA Community. Lene (pronounced Lena) is an award-winning writer, health and disability advocate, and photographer living in Toronto. She’s written several books, including Your Life with Rheumatoid Arthritis: Tools for Managing Treatment, Side Effects and Pain, and 7 Facets: A Meditation on Pain, as well as the award-winning blog, The Seated View. Follow Lene on Twitter @TheSeatedView and on Facebook. Watch her story on HealthCentral.