Transcript Highlights:

• Infringement of patents that claim biological products and for other products or other purposes.
• This bill makes thoughtful reforms to the... process by which biologic drug makers and biosimilar competitors

Bills: SB1040 , SB1041 , SB1095 , SB1096 , SB1097 , SB527

Committee: Senate Senate Judiciary

Keywords: drug competition, product hopping, generic drugs, biosimilars, federal regulations, FTC Act, Federal Trade Commission, sham petitions, competition, public health, unfair competition, healthcare, pharmaceutical, antitrust law, pay-for-delay, reverse payment settlement, interchangeable biologics, brand-name pharmaceuticals, patent settlement, antitrust

Summary: The meeting focused on addressing the high cost of prescription drugs and the abusive practices that contribute to elevated prices affecting American families. Several bills were presented, including proposals to end pay-for-delay deals and to enhance transparency in the operations of pharmacy benefit managers (PBMs). The discussion was notable for its emphasis on consumer protection and ensuring that cheaper generic drugs reach the market more effectively. Members expressed frustration over past attempts to pass similar legislation stalling in the Senate, leading to renewed efforts to push these bills forward.

Bills: HF4438 , HF4467 , HF4379 , SF3402 , HF4349 , HF4064 , HF84 , HF85 , HF3804

Committee: House Health Finance and Policy

Keywords: healthcare, WIC, community health, licensing, speech-language pathology, audiology, contract term limits, healthcare services, provider enrollment, disenrollment, premium payments, medical assistance, substance use disorders, mental health, children's mental health, early childhood, early intervention, consultation grants, Head Start, child care

Transcript Highlights:

• SB 1094 focuses on addressing this issue by focusing on a class of drugs called biologics.
• Biological products are particularly expensive.
• That is quite literally the approval process for the interchangeable designation.
• “But as of right now, biologics and biosimilar or interchangeable biosimilars are on many formularies
• Or they could specify a specific brand of biosimilar or interchangeable biosimilar.

Summary: The Senate Business, Professions and Economic Development Committee heard SB 1094 by Senator Weber Pearson, which would expand pharmacist and health plan authority to substitute biosimilars for reference biologic drugs in order to lower prescription drug costs. The author and supporters, including Blue Shield of California, Sharp HealthCare, and several business and health groups, argued that biologics are a major driver of rising health care spending and that biosimilars can provide substantial savings while maintaining safety and efficacy. The bill also included transparency provisions and committee amendments, including notice requirements and clarifications around substitution and exceptions. Opposition came from the Biotechnology Innovation Organization, the California Rheumatology Alliance, and Biocom, who said the bill was not scientifically justified, could undermine FDA standards, and might lead to unwanted switching, side effects, or delays in care for patients with chronic conditions. They emphasized that pharmacists can already substitute interchangeable biosimilars and that non-interchangeable products can be changed with prescriber contact. Committee discussion focused on patient safety, the meaning of “do not substitute,” the 30-day notice provisions, and the distinction between biosimilars and interchangeable biosimilars. After debate, the committee adopted a due pass as amended motion to the Senate Health Committee. The bill passed the committee on a 10-0 roll call vote and was sent onward.

Transcript Highlights:

• Biological products are particularly expensive.
• That is quite literally the approval process for the interchangeable designation.
• But as of right now, biologics and biosimilar or interchangeable biosimilars are on many formularies.
• of requiring an enrollee to try the therapeutic equivalent, generic, biosimilar, interchangeable biological
• Or they could specify a specific brand of biosimilar or interchangeable biosimilar.

Committee: Senate Business, Professions and Economic Development

Transcript Highlights:

• Biological products are particularly expensive.
• That is quite literally the approval process for the interchangeable designation.
• products, and for non-interchangeable biosimilars it can be done.
• For interchangeable products, and for non-interchangeable biosimilars, it can be done with a simple phone
• “But as of right now, biologics and biosimilars or interchangeable biosimilars are on many formularies

Committee: Senate Business, Professions and Economic Development

Summary: The Senate Business, Professions and Economic Development Committee heard SB 1094 by Senator Weber Pierson, which would expand pharmacist substitution authority for biosimilars and allow health plans to require use of lower-cost generic or biosimilar alternatives when available, unless the prescriber marks “do not substitute.” The author said the bill is intended to lower prescription drug costs, improve access, and require insurers to report on whether substitutions reduce out-of-pocket costs and premium growth. Committee amendments were accepted, including changes to align definitions with federal law, require a link to the FDA Purple Book, add a 30-day advance notice requirement for plan-driven substitutions, and allow exceptions for patients or providers. Supporters included Blue Shield of California, Sharp HealthCare, health plans, CVS, the California Chamber of Commerce, and other business and health care groups, who argued the bill would increase competition, reduce costs, and remove administrative barriers to using FDA-approved biosimilars. Opponents and “opposed unless amended” witnesses, including the Biotechnology Innovation Organization, the California Rheumatology Alliance, and some physician groups, argued the bill goes beyond current FDA interchangeability standards, could undermine physician judgment, and may create patient safety concerns for some chronic-disease patients who react differently to biosimilars or experience problems with multiple switches. Committee members discussed the “do not substitute” option, patient notification, insurance approval, and whether the bill preserves physician discretion. After debate, Senator Arreguín moved the bill, and the committee voted 10-0 to pass SB 1094 as amended to the Senate Health Committee.

Transcript Highlights:

• identical to an already FDA-approved biological product, referred to as the reference biological product
• Interchangeable biological products are a subgroup of biosimilars that meet additional FDA requirements
• biological products or generic medications.
• A pharmacist may substitute an interchangeable biological product unless requested by the patient or
• biological product are less than the out-of-pocket cost for the prescribed biological product.

Committee: House Health Care & Wellness

Transcript Highlights:

• identical to an already FDA-approved biological product, referred to as the reference biological product
• Interchangeable biological products are a subgroup of biosimilars that meet additional FDA requirements
• A pharmacist may substitute an interchangeable biological product unless requested by the patient or
• biological product is less than the out-of-pocket cost for the prescribed biological product.
• Biosimilars and biologics...

Summary: The Health Care and Wellness Committee met on February 10 at 8:30 a.m. and heard two bills. On Engrossed Second Substitute Senate Bill 5594, staff explained that the bill would expand state policy on biosimilars by allowing health carriers to require patients to try a biosimilar before covering the equivalent brand drug starting in 2027, directing exchange plans to increase biosimilar utilization, and changing pharmacist substitution rules so substitution is generally allowed unless the prescriber says not to substitute. The prime sponsor, Sen. Harris, said the bill would lower costs and noted many other states already allow similar substitution. Supporters from health plans and generic/biosimilar manufacturers said biosimilars are safe, effective, and can save consumers and the system money, while a patient advocate raised concerns that the bill may not guarantee lower out-of-pocket costs at the pharmacy counter and suggested preferred formulary placement as a fix. AAM supported the bill with a technical amendment to place biosimilars in the same section as generics and interchangeable products, and the hearing on the bill was closed with no vote taken. The committee also heard Engrossed Senate Bill 5142 on Medicaid network adequacy for post-acute care. Staff said the bill would require the Health Care Authority to adopt network adequacy standards for nursing homes and inpatient rehabilitation facilities, considering community access, regional availability, timeliness, and federal Medicaid rules, with standards due by January 1, 2028 and implementation by July 1, 2028. Sen. Muzzall described it as a follow-up to last year’s bill that would create a pre-approved pathway for patients who are difficult to discharge because continuing care is hard to secure. Testimony from hospital and health system representatives strongly supported the bill, saying patients often remain in hospitals longer than medically necessary because of delays in finding skilled nursing or rehab placements and because single-case agreements are time-consuming and unpredictable, especially in rural areas. Public testimony on SB 5142 was then closed, and the meeting adjourned without any recorded votes or other action.

Transcript Highlights:

• biologic.
• Interchangeable biologics can be substituted without any intervention by the prescriber, and non-interchangeable
• biologic.
• Interchangeable biologics can be substituted without any intervention by the prescriber and non interchangeable
• So, I mean, and they include interchangeable or otherwise.

Committee: Senate Health

Transcript Highlights:

• As someone who worked on biologics... ...understand the intent of this bill.
• between biosimilars and interchangeables that are FDA-approved as interchangeables.
• Will this bill allow substitution of a prescribed biologic with any biosimilar?
• All the interchangeables and everything.
• All the, um, the interchangeables and everything.

Committee: House Health

Transcript Highlights:

• between biosimilars and interchangeables that are FDA-approved as interchangeables.
• Will this bill allow substitution of a prescribed biologic with any biosimilar?
• And what are the studies behind the biosimilars being essentially interchangeable?
• All the interchangeables and everything.
• All the, um, the interchangeables and everything.

Summary: The Assembly Health Committee heard several measures, beginning with SB 331 by Sen. Menjivar, which would require large-group health plans to cover hearing aids for children. The author and supporters described the bill as a long-running effort to address a developmental emergency and reduce out-of-pocket costs for families, while opponents were absent. Testimony from parents, advocates, medical experts, and organizations emphasized the importance of early access to hearing aids; committee members voiced strong support, and the bill was moved on a do-pass basis to Appropriations, with several members requesting to be added as coauthors. The committee then heard SB 608, also by Sen. Menjivar, to expand access to condoms in school-based health centers and related settings and to prevent barriers such as ID checks. Supporters, including students and school health advocates, argued the bill would improve sexual health and reduce stigma, while opponents from family and faith groups argued it would undermine parental authority and normalize early sexual activity. The bill was supported by committee members and moved forward on a do-pass basis to Appropriations. Next, SB 971 by Sen. Choi proposed community-based healthy aging partnerships for older adults, with testimony from the California Senior Legislature and supporters from aging and dementia organizations. The measure was described as voluntary and focused on connection, independence, and local collaboration; there was no opposition, and the committee moved it on a do-pass basis to Appropriations. The committee also heard SB 869 by Sen. Weber Pierson, which would require warning icons and statements on chain restaurant menus for beverages with very high added sugar content. Supporters framed it as a transparency and public health measure, while restaurant and beverage industry representatives opposed it unless amended, citing cost and menu-space concerns; the bill was nevertheless moved on a do-pass basis to Appropriations after a roll call vote, with some members voting no and the measure placed on call. The committee also considered SB 950 by Sen. Weber Pierson, aimed at ensuring timely coverage of FDA-approved, medically necessary treatments for early-onset Alzheimer’s disease on commercial plans. Supporters, including the Alzheimer’s Association and a patient advocate, said the bill would reduce delays and barriers to care, while health plan representatives opposed it over step therapy and utilization-management concerns. Members discussed the limited treatment window and the need for early access, and the bill was moved on a do-pass basis to Appropriations. In addition, SB 490 by Sen. Umberg would set timelines for DHCS investigations of unlicensed sober living homes and allow counties to assist if the department cannot act in time; supporters from Anaheim and a patient-brokering survivor described serious abuse and oversight gaps, while county behavioral health representatives opposed the county role as an unfunded and potentially liability-creating burden. After discussion, the bill was also moved on a do-pass basis to Appropriations. Finally, the committee began hearing SB 1037 by Sen. Weber Pierson on health insurance affordability and rate review, with supporters arguing it would tie premium increases more closely to affordability targets and public reporting; the transcript cuts off before the committee completed action on that measure.

Transcript Highlights:

• Biological products are particularly expensive.
• biologic.
• Interchangeable biologics can be substituted without any intervention by the prescriber, and non-interchangeable
• Interchangeable biologics can be substituted without any intervention by the prescriber and non interchangeable
• So, I mean, and they include interchangeable or otherwise.

Summary: The committee heard several health-related bills, beginning with SB 1124, which would require the California Department of Public Health to create and post lung cancer screening eligibility signage at tobacco point-of-sale locations. The author and supporters said the bill is intended to raise awareness of a screening that many eligible Californians do not know exists; retailers raised concerns about signage size, distribution, and notice to stores. The bill was presented while the committee lacked quorum, so no vote was taken at that time. Members then heard SB 1150, which would require clearer patient notice when cancer cases are reported to the California Cancer Registry. The author and committee chair emphasized patient awareness and privacy, while registry and university stakeholders said they appreciated the amendments and would continue working on the language. SB 1400 followed, proposing changes to Alameda Health System governance to give Alameda County more flexibility and direct oversight; county and labor supporters said the current structure is too rigid for today’s health care environment, and no opposition was heard. The committee also heard SB 1094, which would expand substitution of biosimilars and generics to lower prescription drug costs. Supporters, including health plans and Sharp Health Care, said the bill would reduce premiums and out-of-pocket costs, while opponents from biotechnology and rheumatology groups raised concerns about pharmacist substitution, patient switching, and therapeutic equivalence. After quorum was established, SB 1094 passed 6-0 and was re-referred to Appropriations. The committee then heard SB 1314, which would create a statewide definition for smoke shops, impose a 600-foot buffer from sensitive sites, and restrict nitrous oxide sales; it drew broad support from local government, pediatric, and law enforcement groups and passed 6-0 on call. SB 1309, which would eliminate cost-sharing for medically appropriate lung cancer screening follow-up care, also passed 7-0 and was re-referred to Appropriations after testimony from clinicians, advocates, and insurers. Finally, SB 1199 was introduced to ban copay accumulators, with the sponsor and author arguing it would ensure patient assistance counts toward out-of-pocket maximums and improve medication access.

Transcript Highlights:

• biologic.
• Interchangeable biologics can be substituted without any intervention by the prescriber, and non-interchangeable
• So... ...substitute a non-interchangeable biosimilar as would be allowed under the bill.
• designation... ...what we would call a pretty meaningless interchangeable designation.
• So, I mean, and they include interchangeable or otherwise.

Committee: Senate Health

Summary: The committee heard several health-related bills, beginning with SB 1124 on lung cancer screening awareness. The author and supporters said the bill would require CDPH signage about lung cancer screening eligibility at tobacco point-of-sale locations to address low awareness and low screening rates. Support came from medical students, physicians, and the California Academy of Family Physicians, while retailers raised concerns about sign size, retailer notification, and implementation. Committee members generally supported the bill and noted the need to work through those concerns. SB 1150 sought to require clearer patient notice when cancer cases are reported to the California Cancer Registry. The author described the bill as a response to inconsistent notification practices and privacy concerns, and the chair and other members shared personal stories about learning they or family members were in the registry without knowing it. Cancer registry and university stakeholders expressed appreciation for amendments but continued to have concerns or wanted more time to review the language. The bill was discussed as a patient-awareness measure rather than a change to reporting requirements. The committee also heard SB 1400 on Alameda Health System governance, SB 1094 on biosimilar substitution and health plan policies, SB 1314 on smoke shop regulation and nitrous oxide restrictions, and SB 1309 on eliminating cost-sharing for medically necessary follow-up after lung cancer screening. SB 1400 and SB 1314 drew support from local officials, labor, and public health advocates, with members emphasizing youth protection and local oversight. SB 1094 passed after extensive debate over pharmacist substitution authority and notification requirements, with a 6-0 vote and opposition from biotechnology and physician groups. SB 1309 also passed after members discussed the cost of follow-up care and the value of early detection, despite opposition from health plans over premium impacts; it received a 7-0 vote and was placed on call.

Transcript Highlights:

• </c><02:11:20.760><c> biologic</c><02:11:21.719><c> that</c> essence uh interchangeable biologic that
• essence uh interchangeable biologic that would<02:11:21.960><c> allow</c><02:11:22.239><c> the</c><02
• biological product they interchangeable biological product they don't<02:16:40.080><c> have</c><02:16
• We're going to license this biologic, but we're not going to say it's interchangeable.
• </c><02:20:16.399><c> to</c> interchangeable biologics um and move to interchangeable biologics um and

Committee: House Health, Human Services & Elderly Affairs

Transcript Highlights:

• drug rated as interchangeable.
• <00:31:35.000><c> stating</c><00:31:35.399><c> that</c> interchangeability stating that interchangeability
• Sounds like biologics are a different category of drugs that are not rated as interchangeable.
• ><c> the</c><00:41:21.400><c> kind</c> wrong on that um are biologics the kind wrong on that um are biologics
• </c><00:42:30.720><c> realm</c> just that uh the the the biologic realm just that uh the the the biologic

Committee: Senate Commerce and Consumer Protection

Transcript Highlights:

• After years, we finally found the right biologic.
• After years, we finally found the right biologic.
• that because the nature of biologic switching back is not that simple, time off biologics can lead to
• And it is now a biologic. You know, that is a new development, but it is a biologic.
• And it is now a biologic. You know, that is a new development, but it is a biologic.

Summary: The committee heard several bills, beginning with SB 1312 by Senator Richardson on abandoned endowed-care cemeteries. Richardson described vandalism, theft, and neglect at abandoned cemeteries and said the bill would define abandonment, create a process for local governments to declare a cemetery abandoned, and allow the Bureau to act as conservator of endowment funds. Support came from Marin County, while county and special district groups opposed or had concerns, arguing the bill could shift burdens to local governments or public cemetery districts without enough safeguards. Members expressed general support but noted the need for further work; the bill was discussed but no final vote was taken in the excerpt. The committee then took up SB 758 by Senator Umberg, which would restrict retail sales of nitrous oxide to curb misuse. Supporters, including the League of California Cities, narcotic officers, counties, pediatricians, and other local governments and health groups, said easy access at smoke shops and convenience stores has fueled recreational abuse and health harms. There was no opposition testimony, and members voiced strong support for a statewide approach over city-by-city bans. The bill was well received, with the author closing in support. Dr. Weber-Pierson presented SB 1094, a health care affordability bill on biosimilars and biologic substitution. The bill would allow pharmacists to substitute biosimilars under certain conditions, require advance notice to providers and patients, and add reporting on savings; the author said amendments would strengthen provider notice and preserve the ability to mark prescriptions “do not substitute.” Supporters from health plans, insurers, pharmacies, labor, business, and some provider groups argued the bill would lower costs and expand access. Opponents, including dermatology and rheumatology groups and biotech interests, warned about non-medical switching, prior authorization delays, and patient harm. After extensive discussion, the committee voted 13-0 to pass SB 1094 to the Committee on Health. The committee also passed SB 849 by Dr. Weber-Pierson, which would bar reinstatement of physicians who surrendered their licenses while a sexual misconduct accusation was pending. The Medical Board and California Medical Association were generally supportive or neutral, and members praised the bill’s patient-protection focus. SB 993 by Senator Ochoa Bogh, which limits routine disclosure of identifying information for mental health professionals in correctional and psychiatric settings while preserving complaint processes, also passed unanimously to Appropriations. SB 1002 by Senator Niello, extending the David Hall Act to allow certain patients in remission to continue telehealth care with out-of-state specialists, drew strong patient support but opposition from the Medical Board and CMA over licensure and oversight concerns; the committee voted it out on a split roll with some members not voting. Finally, SB 1263 by Senator McGuire, aimed at protecting wildfire survivors and workers by requiring licensed, trained contractors for post-disaster residential debris removal, received support from labor and the Contractors State License Board, with contractors raising a narrower amendment concern about scope.

Transcript Highlights:

• I mean, they've still got their stuff. ...biological males who are pre-op.
• male, what a biological female is.
• What a biological male, what a biological female is. That's not what I'm asking for here, Mr.
• This old law deals with biological sex.
• sexes and separating the biological sexes.

Summary: The House met with a quorum, opened with the Pledge of Allegiance and prayer, and then moved to second reading of House Bill 1604, a bill addressing standards for strip searches in local jails and related correctional procedures. The bill was described by supporters as implementing and clarifying existing federal law and providing local jails with clearer rules, while opponents argued it would create liability, staffing, bargaining, and operational problems, and would force female correctional officers to perform searches they objected to on privacy, consent, or religious grounds. Members debated a series of amendments, most of which were rejected. Amendment 1470, changing the implementation date from 2025 to 2026, was adopted. Amendment 1492, which would have added intent language and liability protections, failed. Amendment 1494, requiring same-sex staff for invasive searches with a medical exception, failed. Amendment 1493, creating a religious accommodation process for staff, failed. Amendment 1491, focused on consent and boundaries for female officers, failed on a recorded vote of 37 yeas and 50 nays. Amendments 1495, 1496, and 1497, which would have expanded exigent circumstances, limited repeated gender-identity changes, or allowed temporary restraint when no appropriate search staff were available, also failed. A striking amendment to replace the bill entirely was likewise rejected. On final passage, supporters said the bill would help local officials comply with federal and state requirements while protecting dignity and safety for incarcerated people. Opponents repeated concerns that the bill would be difficult to administer and would burden or endanger staff, especially women officers. The House then passed engrossed House Bill 1604 by a vote of 56 yeas to 39 nays, with three excused, and adjourned floor action for the day.

Transcript Highlights:

• as interchangeable.
• First, biologics now account for approximately 45% of drug spending.
• as interchangeable.
• as interchangeable.
• </c> to. and they might try a new biologic to. and they might try a new biologic that's<00:37:27.760>

Committee: House Health Finance and Policy

Transcript Highlights:

• This revision adds an exclusion to step therapy protocol exceptions for interchangeable biologics and
• It's, well, every biologic, it's its own.
• I know the list of biologics has grown.
• There were very few biologics back then.
• It depends how many biologics for that particular, I mean, biosimilar for that particular biologic drug

Summary: The committee heard several bills, but much of the meeting focused on House Bill 306, which would require disclosure when a consumer is interacting with a chatbot rather than a human. Sponsor Senator Townsend described it as a consumer protection measure and said the bill is meant to keep pace with rapidly changing AI technology. Committee members and witnesses raised concerns about the bill’s enforcement structure, especially private rights of action and penalties that could apply even without actual consumer harm. The Department of Justice said the bill would apply where the conduct has a Delaware nexus, and that the disclosure requirement is the key consumer protection. Industry witnesses and chambers of commerce opposed the bill as drafted, arguing it would create broad compliance burdens and expose businesses to excessive litigation risk without a harm requirement or clearer safe harbor language. Earlier in the meeting, the committee discussed House Bill 429, which would update Delaware’s step therapy exception process to include biosimilars and interchangeable biologics. Senator Poore and supporters from Highmark and the Department of Insurance said the bill would modernize insurance law, improve access to effective treatments, and reduce costs; they cited national savings from biosimilars and said the bill has agency support. Members asked about Delaware-specific savings, patient switching, and how the process would work, but no vote was taken during the discussion. The committee also heard House Bill 310, which would exclude large data centers from Blue Collar Jobs Act tax credits; the sponsor said the bill is intended to ensure large energy users contribute more to state and local revenues, while supporters and opponents debated competitiveness and community impacts. House Bill 406, on allowing insureds to choose their auto repair shop, and Senate Bill 347, a cleanup bill related to medical debt collection and personal property levies, were also presented without opposition in the hearing. House Bill 253, concerning who may receive letters testamentary or of administration, was described as a cleanup to align statute with existing practice. The committee approved the meeting minutes, but the transcript does not show final votes on the bills discussed.

Transcript Highlights:

• After years, we finally found the right biologic.
• Finally, I add that because the nature of biologic switching back is not that simple, time off biologics
• Finally, I add that because the nature of biologic switching back is not that simple, time off biologics
• And it is now a biologic. That is a new development, but it is a biologic.
• And it is now a biologic. You know, that is a new development, but it is a biologic.

Committee: House Business and Professions

Transcript Highlights:

• And it's a term that we use interchangeably.
• male, what a biological female is.
• male, what a biological female is.
• What a biological male, what a biological female is. That's not what I'm asking for here, Mr.
• This old law deals with biological sex.

Summary: The House convened, established a quorum, led the Pledge of Allegiance, and heard a prayer from a Scouting America leader. After caucuses and routine introduction and committee-report actions, the chamber took up House Bill 1604, dealing with standards for strip searches in local jails and related correctional procedures. Supporters said the bill would align local jails with existing federal law and provide clearer standards for staff and administrators; opponents argued it would create liability, staffing, and operational problems, and force female officers into unwanted searches of male inmates. A series of amendments were debated and mostly rejected. Failed amendments sought to add liability protections, require same-sex searches, create religious accommodations for staff, broaden exigent circumstances, limit how often an inmate could change gender identity, and allow staff to decline searches or delay them when no appropriate staff were available. One amendment changing the implementation date from 2025 to 2026 was adopted. The final striking amendment was also defeated. The bill was then advanced to third reading and final passage as Engrossed House Bill 1604. In closing debate, supporters emphasized public safety, dignity, and compliance with federal standards, while opponents repeated concerns about consent, staffing, and jail administration. The House passed the bill 56-39, with three excused, and the floor session ended afterward.