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50 State Network Advocate Talking Points: Biosimilars

  1. As patients, our core concerns are to safeguard safety and the physician-patient relationship. Physicians and their patients are in the best position to determine appropriate therapies.
  2. Transparency and communication between patients and their treatment teams is paramount. The core principles that we believe should guide substitution policies for biosimilars under state law include:
    1. Substitution should occur only when the FDA has designated a biologic product as interchangeable.
    2. The prescribing physician should be able to prevent substitution.
    3. The prescribing physician should be notified of any substitution.
    4. The patient, or the patient’s authorized representative, should, at a minimum, be notified of any substitution.
    5. The pharmacist and the physician should keep records of any substitution