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 meeting with the FDA and planning clinical trials.

Landsberg said Civica’s work is phased: the glargine (long‑acting insulin) program is under active development and Civica has begun planning for a fast‑acting insulin program that the company expects to develop more quickly after the first product. HCAI staff told senators the department is reviewing Civica’s nonpublic development updates and that outside experts consider Civica’s timeline “within industry norms,” though not as fast as the legislature and advocates had hoped.

Officials did not provide a fixed date for FDA submission and approval. Landsberg said Civica is preparing clinical trials and that a regulatory filing would follow completion of those studies; HCAI staff said an FDA review period after filing typically takes on the order of about a year but that trial and filing timing depends on study outcomes.

Naloxone, procurement and distribution
Landsberg also reported that CalRx executed a contract with Amneal Pharmaceuticals in 2024 to supply a CalRx‑branded naloxone twin pack for $24 per twin pack that the department describes as roughly a 40% savings compared with a prior state contract. HCAI said the contract supplies the Department of Health Care Services’ Narcan distribution program (the NDP) and that since May 2024 the Amneal product has been the primary supplier for the NDP. Landsberg said the NDP has distributed over 5,000,000 naloxone twin packs since the program began and estimated the program has reversed nearly 297,000 overdoses.

Target list and other drugs under consideration
HCAI said it considered public‑health impact, population size, unit price and whether new entrants could address market failures to identify priority drugs. Landsberg said the agency has developed a list of 15 priority drugs across 12 disease categories for initial focus; examples discussed in the hearing included epinephrine (EpiPen alternatives), asthma inhalers, certain cancer generics, and GLP‑1 diabetes/weight‑loss medications such as semaglutide (Ozempic/Wegovy). HCAI is evaluating options for market interventions, including biosimilars and partnerships with domestic manufacturers.

Manufacturing in California and state facility feasibility
Committee members asked whether HCAI intended to build a California‑based manufacturing facility. Landsberg said HCAI and the governor’s Office of Business and Economic Development have discussed feasibility and that HCAI is conducting due diligence; she had no near‑term announcement about a California plant and noted Civica has already established production capacity at a U.S. site (described in testimony as Virginia) that is manufacturing pens and vials to support the clinical program.

Stakeholder views and interim protections
Advocates and clinicians urged HCAI and the Legislature to pursue near‑term protections while CalRx products are developed. The American Diabetes Association told the committee that state action is urgently needed because people with diabetes are rationing insulin; clinician groups and oncologists asked CalRx to include cancer generics and to prioritize items that address shortages. HCAI said CalRx’s naloxone initiative demonstrates the program’s ability to supply low‑cost medicines quickly when an on‑market manufacturer will partner.

What HCAI asked of the Legislature
Landsberg urged continued support for CalRx’s mandate-driven market work and said HCAI will report results as Civica advances trials and as procurement programs (like naloxone) scale. The agency also signaled further updates will be posted on progress and that it will continue consultations with stakeholders, PBMs, wholesalers and health plans to support distribution once products are approved.

Ending note
HCAI officials asked the committee to view CalRx as one element of a broader drug‑cost strategy while the Legislature and administration weigh complementary policies — from PBM transparency to other market interventions — to protect consumers now and expand long‑term supply competition.

Speakers quoted: Elizabeth Landsberg, Michael Valle, and other HCAI/CalRx officials; public advocates and health‑care providers from the hearing.