Arthritis Foundation Legislative Position Statements

Arthritis Foundation Position Statement on Biosimilar Substitution

Issue

The Affordable Care Act creates a regulatory pathway for approving a new generation of biologic medications called “biosimilars”. Biosimilar medications have the potential to provide safe and effective treatment to people with arthritis at a significantly lower cost than the name-brand biologic medications.

Background

For years, biologic medical products have offered tremendous therapeutic benefits to thousands of patients with arthritis and have also helped many others living with complex chronic diseases.

As a result of the Affordable Care Act, new pathways have emerged to assist in the recognition of new biologic products that may be considered “biosimilar” to a currently recognized or reference biologic product.

This new class of biosimilars will be entering the marketplace in the near term. These complex, genetically engineered products offer new, and hopefully more affordable, treatment opportunities for people with forms of inflammatory autoimmune arthritis. Through special review processes conducted by the FDA, some of these biosimilar products may be deemed therapeutically equivalent or interchangeable with an original biologic or reference product.

In the future, interchangeable biosimilars recognized by the FDA may be substituted for an approved biologic. However, as both biologics and biosimilars are complex treatments requiring careful therapeutic monitoring, pathways for substitution require communication and transparency in all pharmacy transactions.

Arthritis Foundation Position

The Arthritis Foundation supports legislation that provides a pathway for biosimilar substitution and should provide the following:

  • Communication to the patient when substitution occurs.
  • Communication to the prescriber within 48 hours of the substitution.
  • Retention of substitution records for a minimum of 5 years.
  • Permission for a physician to override substitution when patients are stable on a prescribed biologic.
  • FDA approvals on biosimilar medications that are therapeutically equivalent and interchangeable to the original biologic.
  • An individualized and unique name for the biosimilar medication that is noticeable different than the referenced biologic.

Download and share this information with family, friends and your legislators!

Biosimilar Webinar

Watch our Biosimilars and Advocacy webinar to learn more, featuring Dr. Harry Gewanter, a pediatric rheumatologist from Richmond, VA, and Mark Guimond, Arthritis Foundation Director of State Legislative Affairs.

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