Do you know what biosimilar medicines do, and why they are important? If you do, then you might be in limited company. The American Autoimmune Related Diseases Association (AARDA), a national nonprofit health organization focusing on awareness of autoimmune diseases such as Multiple Sclerosis, has published a white paper to make the public aware of biosmiliars, what they do, and how they differ from other drug types. The publishing of the white paper was in response to a survey that revealed widespread lack of knowledge about this important new class of medications in the United States.
The white paper is available on AARDA’s web site: www.aarda.org.
The survey found that more than 80 percent of 362 AARDA members responding did not know what biosimilar medicines were and about 52 percent did not know why they might be different from other classes of drugs.
Autoimmune diseases include multiple sclerosis (MS), a progressive disorder in which the body attacks its own myelin, resulting in neurological damage, disability and sensory problems. Myelin wraps around nerve cells, allowing them to transmit information more quickly and efficiently. Biosimilars could represent an important new type of treatment for MS — and these medications might help to protect myelin.
Virginia Ladd, President and Executive Director of AARDA noted: “Unlike chemically based drugs, biologic medicines have the unique ability to target the underlying cause of a disease, representing a huge breakthrough for patients suffering from many serious autoimmune diseases. The results of our member survey illuminated just how limited awareness is around these life-saving medications — especially among those who need them most.”
The U.S. Food and Drug Administration (FDA) is currently working to finalize guidelines for the approval of biosimilars. Biosimilars are defined as similar but not the same as biological molecules.
The white paper contains important information on biosimilars and why knowledge of them is important for people with autoimmune diseases such as MS. Topics covered include explanations on:
1) how biologic medicines are made from complex molecules of living material and not synthetic compounds, and how these therapies are used to treat patients with severe medical conditions.
2) how biologic medicines effectively treat many different autoimmune diseases.
3) why biosimilar drugs are not the same as “generics.”
4) what the safety concerns are when switching between biologic and biosimilar products.
5) what are the policy issues regarding US FDA approval of biosimilar medicines.
Ladd additionally stated, “It is our hope that biosimilars will increase patient access to these treatments by lowering the cost of this class of drugs. However, patient safety must come first. The white paper will help to ensure all patients living with complex medical conditions are able to understand this category of drugs, be aware of their treatment options and safety issues and work to ensure that the FDA enacts policies that protect patient safety.”