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SB 5594

Concerning the operation of fully autonomous vehicles.

2023-2024 Regular Session Introduced by Matt Boehnke and 3 co-sponsors

Expands pharmacist substitution to include biosimilars (interchangeables) for biologics, to lower costs, with traceability and clear exception timelines.

Public hearing in the Senate Committee on Transportation at 4:00 PM.
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Bill Summary · SB 5594

Bill Summary — SB 5594 (2025): Concerning biosimilar medicines

Status: By resolution, returned to Senate Rules Committee for third reading (last action 2025-04-27)
Introduced: January 30, 2025
Sponsors: Senate Committee on Health & Long-Term Care (originally Senators Harris, Cleveland, Hasegawa, Shewmake)

Purpose / Intent

The bill aims to reduce prescription drug costs by increasing patient access to biosimilar medicines and removing statutory barriers that limit substitution and use of biosimilars. It directs insurers, pharmacy practice rules, and state-purchased health plans to encourage greater biosimilar and interchangeable biological product utilization while preserving exception processes for patients who cannot safely switch.

Key provisions

  • Pharmacy substitution rules

    • Allows pharmacists to substitute a therapeutically equivalent generic drug or an FDA-designated interchangeable biological product unless the prescriber explicitly indicates “do not substitute.”
    • For oral prescriptions, substitution is permitted unless the prescriber or the prescriber’s agent instructs otherwise.
    • Removes statutory requirements that every prescription form include two signature lines (“dispense as written” and “substitution permitted”) and that every prescription must contain substitution instructions.
    • Requires pharmacists to record the manufacturer of the product dispensed on the prescription file (or in a readily retrievable separate record) to support traceability.

  • Health carrier / utilization management (step therapy)

    • Beginning January 1, 2026, a health carrier or prescription drug utilization management entity may require a patient to first try a biosimilar prior to covering the equivalent branded biologic (i.e., use of step therapy is permitted to encourage biosimilar use).
    • Maintains and clarifies requirements for medical exception processes: accessible website-based exception procedures, disclosure of criteria, specific timelines for nonurgent (3 business days) and urgent (1 business day) exception decisions, emergency supply fills while exceptions are processed, and deeming requests approved if timelines are missed.

  • State-procured Qualified Health Plans (QHPs)

    • Health Care Authority (HCA) contracted QHPs offered under state procurement must include pharmacy benefit requirements that address increasing use of generics and biosimilars and use of evidence-based formularies.

  • Other

    • No new appropriation; fiscal note available.
    • Effective date: 90 days after adjournment of the session in which the bill is passed.

Who is affected

  • Patients receiving biologic therapies (possible exposure to step-therapy requiring trials of biosimilars)
  • Prescribers (must indicate if substitution is prohibited)
  • Pharmacists (expanded authority to substitute; new documentation requirement)
  • Health carriers, PBMs and prescription drug utilization management entities (may implement biosimilar-first policies and must run exception processes per timelines)
  • Health Care Authority and carriers offering state-procured QHPs (must incorporate biosimilar/utilization goals)

Procedural timeline / legislative action

  • Introduced 01/30/2025; public hearings in Senate and House committees in Feb–Mar 2025.
  • Passed House (3/11/2025) by vote 49–0 after substitution and floor amendments.
  • Returned to Senate Rules Committee for third reading (04/27/2025).

Potential impacts / considerations

  • Intended to lower biologic drug spending by increasing biosimilar uptake and enabling easier substitution at pharmacy level.
  • May increase use of step therapy requiring biosimilar trials; the bill preserves an exception process with defined timelines and emergency supply provisions to reduce interruption risk.
  • Changes to prescription form rules reduce administrative burden for prescribers but increase the importance of clear communication when substitution should be blocked.
  • Manufacturer recording requirement supports pharmacovigilance and product tracing.

For detailed statutory changes, SB 5594 amends RCW 48.43.420, 41.05.410, 69.41.120, and 69.41.125 and creates a new section related to legislative intent on biosimilars.

Compiled from official sources — confirm details with the bill’s official record.

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