Biosimilar Therapeutics Substitution: American Academy of Neurology Position Statement.

Abstract

Biologic therapeutics have revolutionized treatment of disorders for which there were previously limited options. Biologic products are typically very expensive. However, the emergence of biosimilars (a biologic product that is nearly identical to a Food and Drug Administration [FDA]-approved "branded" version) offers an opportunity to reduce costs after the branded product's period of patent protection ends. Despite the promise of biosimilars, some physicians have expressed concern regarding interchangeability, especially in specific patient populations. The American Academy of Neurology (AAN) supports the cost-saving potential of biosimilar therapeutics while emphasizing the importance of a balance between reducing costs, maintaining clinical efficacy, and preserving the integrity of the physician-patient relationship. This position statement from the AAN offers a framework to aid neurologists in deciding whether to switch a patient from a branded biologic product to a biosimilar therapeutic. This framework aligns with broader AAN policies on drug pricing and medical decision-making autonomy.