California Senate Bill 598, which would prohibit pharmacists from substituting biosimilars for a prescribed biologic, unless the biosimilar is an interchangeable product which would not need physician consent or if the biosimilar exceeds the cost of the brand-name drug, recently passed the California State Assembly by a vote of 58-4. The bill which has since passed the Ca. State Senate by a vote of 30-2 has yet to be signed into law by Governor Jerry Brown and has prompted extensive lobbying efforts both in support of and against its passage.

Specifically, Bill 598 seeks to add restrictive language to the Business and Professions Code including:

A pharmacist filling a prescription order for a prescribed biological product may select a biosimilar only if both of the following conditions are met:

  • The product selected as a biosimilar has been approved by the federal Food and Drug Administration (FDA) under the 351(k) pathway of the federal Public Health Service Act (42 U.S.C. Sec. 262(k)) and has been determined to be interchangeable with the prescribed biological product.
  • The prescriber does not personally indicate “Do not substitute,” or words of similar meaning, in the manner provided in subdivision (c).

This is just the latest example of a state legislature looking to address the issue of biosimilar substitution and the potential regulation of dispensing of interchangeable biosimilar products. Of course, states currently have their own laws regulating generic substitution for small molecule pharmaceuticals; generally, as long as a generic drug is deemed “therapeutically equivalent” (typically determined by the Orange Book), it may be used by a pharmacist to substitute a prescribed branded drug.

As for biosimilars, thirteen (13) states to date including Illinois, Florida, Indiana, Maryland, and Texas have rejected more restrictive conditions for interchangeable biosimilar substitution. Meanwhile, four (4) states — Oregon, Utah, Virginia and North Dakota — have adopted substitution restrictions similar to that set forth in California Senate Bill 598. Oregon, Utah, and Virginia, however, included sunset provisions in their respective legislation which experts suggest will render legislation moot before biosimilars come to market. North Dakota’s law is not limited by a sunset provision.

Gibbons will continue to monitor the status of California Senate Bill 598, as well as analagous legislation throughout the country and other important developments in the field of biosimilars.

Estelle J. Tsevdos is a Director in the Gibbons Intellectual Property Department.