ERIC Submits Comments on Arkansas Biosimilar Bill

Today, ERIC submitted comments to the Arkansas House Public Health, Welfare and Labor Committee on House Bill 1269, which would allow pharmacists to make biosimilar substitutions. The proposed language permits prescribers to limit biosimilar substitution, which ERIC supports since it should be within the provider’s discretion what treatment is best for the patient. We were also supportive of the reasonable time period (five business days) for a pharmacist to notify the prescriber of a biosimilar substitution and of requiring a pharmacist to explain the cost difference between a biosimilar and the reference biologic only when requested by the patient.

Interchangeability is the sticking point in many state legislative proposals on biosimilar substitution, and this bill has the same issue. Essentially all only permit substitution to occur if the biosimilar is deemed interchangeable, and currently, no biosimilar has that status. However, to be approved by the FDA, a biosimilar must be proven safe and effective, and it can have no clinically meaningful differences from the existing reference product. Interchangeability is an additional step beyond FDA approval. Therefore, in our comments, we stated, “…requiring [interchangeability] in order for substitution to occur means this legislation, as currently written, will do little to increase cost savings to the health care system.” Instead, we suggested permitting substitution to occur with a patient’s consent if the FDA has approved a biosimilar for a given reference (branded) biologic.

The Committee will hold a hearing on the bill on March 5, and we will continue to work with the State to ensure that unnecessary burdens to biosimilar utilization are not put into place.

Click here to read our comments in their entirety, and please let me know if you have any questions.

Article by Adam Greathouse, Health Care Policy Senior Associate