Letters

Alliance of Specialty Medicine Calls on Congress to Address Impacts of the Biosimilar Red Tape Elimination Act (S.2305)

November 6, 2024
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  • Drugs and Devices
  • The Honorable Chuck Schumer
    Majority Leader
    United States Senate
    322 Hart Senate Office Building
    Washington, DC 20510
  • The Honorable Mike Johnson
    Speaker
    United States House of Representatives
    568 Cannon House Office Building
    Washington, DC 20515
  • The Honorable Mitch McConnell
    Minority Leader
    United States Senate
    317 Russell Senate Office Building
    Washington, DC 20510
  • The Honorable Hakeen Jeffries
    Minority Leader
    United States House of Representatives
    2433 Rayburn House Office Building
    Washington, DC 20515


RE: The Biosimilar Red Tape Elimination Act (S.2305)

Dear Majority Leader Schumer, Speaker Johnson, Minority Leader McConnell, and Minority Leader Jeffries:

The Alliance of Specialty Medicine (Alliance) is a coalition of national medical specialty societies representing more than 100,000 physicians and surgeons. We are dedicated to the development of sound health care policy that fosters patient access to the highest quality specialty care. The undersigned member organizations of the Alliance of Specialty Medicine write to express our concerns related to the Biosimilar Red Tape Elimination Act (S.2305) regarding the designation of interchangeable biosimilar products. Specifically, we are concerned with the presumption that an approved biosimilar product may be deemed interchangeable with the reference biologic product without requiring additional switching studies by the biopharmaceutical manufacturer.

The Alliance has closely engaged in the development of state policies related to biosimilar prescribing and substitution, which are currently in effect in 35 states. We are acutely monitoring the safety considerations that should be considered as more biosimilar versions of existing biologic medicines become treatment options for our patients. Many physician specialties, including retina, gastroenterology, eye surgery,
rheumatology and plastic surgery, work directly with biologic products, which are complex molecules. Depending on the patient’s unique biology, disease progression, and other clinical factors, one biologic or biosimilar therapy may be clinically indicated, recommended and prescribed over another.

Read full letter here.