Sen. Weber Pearson's bill to expand biosimilar substitution advances from committee

Sen. Weber Pearson's SB 1094, which would allow pharmacists to substitute FDA'approved biosimilars for prescribed biologic medicines unless the prescriber indicates "do not substitute," was advanced by the Senate Business, Professions and Economic Development Committee on a 10-0 roll call.

The bill's author accepted committee amendments intended to clarify patient protections and transparency. The changes add the word "safe" to legislative intent language, require the state board to link to the FDA'maintained "Purple Book" rather than maintain its own list, define "reference product" consistent with federal law, and require health plans to give at least 30 days' advance notice to an enrollee and the prescribing provider before enforcing a substitution; the enrollee or provider may request an exception.

Why it matters: Biologic drugs are expensive and account for a disproportionate share of drug spending. Sen. Weber Pearson told the committee that biosimilars and generics can lower cost without compromising care and that the bill is designed to increase uptake of biosimilars while preserving prescriber discretion. Supporters said the change would reduce patient out-of-pocket costs and overall premium growth; opponents warned against treating non'interchangeable biosimilars as automatically substitutable and urged preserving the FDA's role in interchangeability determinations.

Supporters' case: Andrew Keefer, vice president of state government affairs for Blue Shield of California, said "The health care system is broken" and argued current law prevents plans from helping members access lower-cost biosimilars at the pharmacy counter. Suzanne Shay, vice president of pharmacy at Sharp HealthCare, described administrative hurdles and said substitution authority would streamline care and reduce delays. Multiple industry and advocacy groups stated support on the record, including insurers, pharmacy benefit managers and trade groups.

Opponents' concerns: Brian Warren of the Biotechnology Innovation Organization said the bill "treats all biosimilars as if they are interchangeable" and expressed concern that non'interchangeable biosimilars are not held to the same clinical standard as FDA'designated interchangeable products. Tim Madden of the California Rheumatology Alliance said some patients react differently after switching, citing reports of rashes and flare-ups and warning that multiple switches can complicate care and clinician oversight.

Committee debate and safeguards: Committee members pressed both sides on frequency of adverse reactions, physician notification and practical effects for patients who need immediate medication. Witnesses and the author said physicians would retain the ability to mark "do not substitute" on prescriptions, and the accepted amendment requires at least 30 days' notice to prescribers and enrollees before a plan-enforced substitution takes effect (the bill's language aligns that notice period with existing Medicare practice for certain products). The committee chair and author emphasized the bill does not remove physician discretion and includes reporting requirements to track impacts on out-of-pocket costs and premiums.

Outcome and next steps: Sen. Archuleta moved the bill; the committee approved SB 1094 as amended and referred it to the Senate Health Committee on a 10-0 vote. No effective date or further fiscal specifics were adopted in committee; the measure will proceed to policy consideration in the Health Committee.

Quotes (selected): "I will be accepting the committee amendments," Sen. Weber Pearson said while presenting the bill. Andrew Keefer said, "The health care system is broken." Brian Warren testified that treating biosimilars as interchangeable "undermines the authority of the FDA." Tim Madden noted clinician concerns that switching can sometimes cause reactions, including rashes and flares.

What was not decided: The committee did not adopt additional limits on substitution tied to FDA interchangeability designations; opponents sought an amendment to restrict automatic substitution to products the FDA has designated interchangeable, while the author and supporters pointed to the bill's notice and exception processes as protections. Reimbursement for out-of-pocket purchases made while an insurer processes an exception was described as a plan-level matter and is not specified in the bill.

Next procedural step: SB 1094, as amended, goes to the Senate Health Committee for further consideration.