Arthritis Foundation urges FDA to expeditiously create regulatory pathway for biosimilars

Arthritis Foundation patient advocate, Jan Wyatt, PhD, will provide oral testimony on behalf of the approximately 4 million Americans with inflammatory arthritis at a Food and Drug Administration (FDA) hearing today.  The hearing will focus on issues and challenges associated with an approval pathway for biologic products that are highly similar "biosimilar" or interchangeable with FDA-licensed products.  

"The Arthritis Foundation commends the FDA for holding today's hearing to help guide the agency in moving forward with regulating these potential new products," says Amy Melnick, MPA, Arthritis Foundation vice president of advocacy.

Wyatt, who was diagnosed with rheumatoid arthritis in 2004, credits innovative scientific breakthroughs in biomedical research and use of a biologic for radically altering the trajectory of her disease.  "A little over 10 years ago, a diagnosis of rheumatoid arthritis or juvenile arthritis would have meant a future of pain, loss of function and limited mobility," says Wyatt.  "I am truly grateful for these life-transforming therapies."

Biologic therapies are regarded as highly effective forms of treatment for the management of symptoms and to reduce the risk of bone and joint damage for people with rheumatoid and other inflammatory forms of arthritis.  Unfortunately, access to biologic therapies is limited or non-existent for many people due to their high cost.  For these individuals, biosimilars represent great promise to improve their access to safe, effective and cost-effective options.

As new therapies are introduced, the Arthritis Foundation strongly recommends that the FDA require post-marketing studies of the newly approved biologics and biosimilars, including possible registry participation for surveillance purposes.  In addition, the Arthritis Foundation believes more research is needed to guide the selection of the best biologic for the individual.  Patients fortunate enough to have access to existing therapies often must try several therapies before finding one that works.

"Patients with inflammatory arthritis need to be assured that biologic and biosimilar therapies will be of high quality, accessible, safe and effective," says Wyatt.

The Arthritis Foundation welcomes the approval of new, safe and effective biosimilars and urges the FDA to:

• Move expeditiously to create a regulatory pathway that provides appropriate oversight, ensures patient safety and ensures access to these potentially lower-cost biologic products.
• Require clinical studies to ensure biosimilars work as well as approved products in the targeted population.
• Require rigorous post-marketing surveillance for any newly approved biologic and/or biosimilar and to seek ways to improve the current system for reporting and responding to adverse events.
• Reach out to patient organizations, such as the Arthritis Foundation, to improve its communication efforts regarding biologic products.