CalRx update: Civica progress on biosimilar insulin, naloxone deal in distribution and list of 15 priority drugs

State health officials updated the Senate Budget and Fiscal Review Committee on CalRx activities aimed at lowering prescription drug prices, reporting progress on a Civica biosimilar-insulin project, a low-cost naloxone contract and a prioritized list of drugs CalRx is exploring for market interventions.

Why it matters: Californians and lawmakers pressed HCAI and CalRx for specific timelines and asked what interim consumer protections are feasible while manufacturing, clinical testing and Food and Drug Administration (FDA) review proceed. Insulin affordability was a recurrent focus; witnesses, advocates and clinicians said many Californians continue to ration insulin while the state’s program proceeds through multi-step manufacturing and regulatory processes.

Civica, biosimilar insulin and timeline Elizabeth Landsberg, director of the Health Care Access and Information (HCAI) office, said the March 2023 $50 million CalRx–Civica agreement remains the foundation of the state’s insulin work and that Civica has completed several manufacturing and regulatory milestones: Landsberg told the committee Civica has "passed initial facility inspections by regulatory authorities and has started manufacturing both glargine vials and pens at a new United States facility to support the clinical trial." She added Civica is conducting product quality and stability testing and has been…