The American Autoimmune Related Diseases Association (AARDA) recently released a white paper to inform and educate AARDA members and the patient community in general about biosimilar medicines (drugs similar but not identical to original biologic medicines) and their potential safety concerns.
AARDA is a national nonprofit health organization working to increase awareness regarding autoimmunity, promoting a cooperative research effort in the search for better therapies for autoimmune diseases, such as systemic lupus erythematosus (SLE), rheumatoid arthritis and multiple sclerosis. AARDA’s white paper was conceived after a survey revealed that the majority of patients are uninformed about biosimilar medicines that will soon be approved in the United States. Among 362 AARDA members, from which 96% have an autoimmune disease, more than 80% were unaware of what biosimilar medicines are and approximately 52% did not know the difference between biologic and chemical drugs.
“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,” explained the President and Executive Director of AARDA Virginia Ladd in a news release. “The results of our member survey illuminated just how limited awareness is around these life-saving medications — especially among those who need them most.”
AARDA’s white paper offers a comprehensive review about biologic medicines for the treatment of several diseases such as autoimmune diseases and cancer. The U.S. Food and Drug Administration (FDA) is currently working on their guidelines for biosimilars approval.
Several topics are covered in AARDA’s white paper with the aim to increase awareness, namely:
• biologic medicines as the products of living material and their therapeutic impact in individuals with severe clinical conditions.
• how biologic medicines are effective in the treatment of patients with autoimmune diseases.
• why biosimilar medicines are not considered “generic” versions of biologics.
• safety concerns when patients exchange therapy between biologic and biosimilar drugs.
• policy issues in the U.S concerning the approval of biosimilar medicines.
The Affordable Care Act (ACA) defined a strategy for approval of biosimilar drugs by the FDA in the U.S., for interchangeable use with brand-name biologic medicines. The FDA will soon release guidelines for biosimilar drug approval based on a clinical and analytical comparison to the commercially available biologic products, especially now that the patent protection for biologic therapies is reaching its end.
Ladd added, “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.”
For more information of the AARDA’s white paper or for free download, click here.