Senate Standing Committee on Business, Professions and Economic Development

Welcome. Good morning, everyone. Welcome to the Senate Business Professions and Economic Development Committee. Committee announcements are for today that we have one bill on our agenda, SB 1094 by Senator Weber Pierson. We do not have quorum yet, so we are gonna wait for other members as they are landing and coming here.

But we're gonna begin as a subcommittee. I do just wanna flag for you all that the way that we typically have it is that the author will present their bill here at this lectern, and then we will have witnesses both in support and opposition at the microphone standing there behind the guardrails. Each individual will have two minutes. They will actually be timed and then the me too's will come together both opposition and support together.

And looks like we now just have a quorum, so I'd like to pause just for a moment for a committee assistant to call role and establish quorum.

Here.

Wahab here. Choi?

Wahab?

Here.

Choi here. Archuleta?

Here.

Adagun here. Caballero?

Archuleta here. Arreguin?

Here.

Grayson?

Grayson here. Menjivar, Nilo, Smallwood Cuevas, Strickland, Umburg.

Here.

Here.

Umberg here.

Alright. We have quorum. We'll begin our hearing with file item number one, SB 1094. Senator Weber Pierson, you are welcome to present your bill. And prior to beginning, I just wanna, make sure that you acknowledge and accept the amendments noted in the analysis.

Yep. That's the first thing I was gonna say after I said good morning and thank you to the chair and members. I will be accepting the committee amendments, and I wanna thank, the committee and the committee staff for working so hard on this particular bill. Half of all Californians report that their health care costs are rising faster than their paychecks. For too many California, this means delaying care or going without it altogether.

One underlying driver of rising health care premiums is the cost of prescription drugs, which has increased by 72% since 2017. SB 1092 focuses excuse me, ten ninety four focuses on addressing this issue by focusing on a class of drugs called biologics. Biological products are particularly expensive. Despite comprising only 5% of all prescriptions, biologics account for over half of all drug spending And this is due to the complex method by which they are manufactured, which was actually discussed very well in the committee background.

But examples of biologics include Humira, which are used to treat autoimmune conditions like rheumatoid arthritis, Crohn's, psoriatic arthritis along with Remicade, Keytruda.

These are some names that you may have seen on some commercials. Keytruda is used to treat over 18 types of cancers, including non Hodgkin's lymphoma, melanoma, and triple triple negative breast cancer. These are critical treatments, but their high price tag are putting a real strain on patients and our health care system in general. Fortunately, we do have an opportunity to lower cost without compromising care.

Lower cost alternatives like generics and biosimilars offer the same safety and efficacy as their brand name counterparts, but often at a significantly reduced price.

In some cases, like with the biologic Humira, switching to a biosimilar can reduce the cost by as much as 85% And when biosimilars enter the market, they introduce a competition that helps bring prices down across the board. Yet, despite these clear benefits, biosimilar uptake remains relatively low. This bill takes a practical approach to promoting biosimilar use. It allows pharmacists to substitute biosimilar for biologic when appropriate unless a prescriber otherwise checks do not substitute in the prescription.

It also allows health plans to require patients to try a generic or biosimilar when it is available at the same or lower cost, again, unless the prescriber indicates otherwise by checking or adding do not substitute to the prescription.

Importantly, this bill also increases transparency and accountability. It requires insurers to report how often these substitutes often re actually reduce patients' out of pocket cost and what impacts they have on premium growth. This was extremely important because I wanted to make sure that as they are paying less, the people who actually need the medications will be able to see what's happening with those funds.

And with me today to explain how this bill will make health care more affordable while maintaining high quality care is Andrew Kiefer from Blue Shield of California and Suzanne Hsieh from Sharp Health Care. Thank you.

Good morning. Senators, chair, thank you very much for the opportunity to be here. My name is Andrew Keefer. I'm the vice president of state government affairs for Blue Shield of California. And, let me just be blunt.

The healthcare system is broken. It's too darn expensive. It's bankrupting consumers. It's bankrupting taxpayers. And chief among those, elements of the delivery system that are broken is the pharmacy delivery system.

It was cited in the California Healthcare Foundation. There is ubiquitous concern across California. No matter who you are, no matter how much money you make, what you look like, you're concerned with the cost of healthcare. This measure is extremely important because there's a function of state law that precludes health plans and members like ours from achieving the savings that, the Senator just described. We, because of state law, cannot have our members receive lower cost, equally effective, FDA approved biosimilars at the at the pharmacy counter.

In addition to that, we can't help them switch to move them from the higher cost branded version of those medications. This is fully within the purview of of of California. We regulate our pharmacist, pharmacy scope practice. We did this, frankly, with generics. Long ago, the Federal Government didn't say hide in your hair about it.

We, as a state, said it's important for us to advocate and facilitate the adoption of of generics. With that in mind, I know I'm at my time here. This is a tremendous savings, for consumers and taxpayers and had asked for your aye vote.

Good morning. My name is Suzanne Shea. I'm a licensed pharmacist with more than forty years of experience. I currently serve as the vice president of pharmacy and clinical nutrition at Sharp HealthCare in San Diego. I oversee medication use, compliance, and affordability across the system, including co chairing our drug formulary committee.

Sharp HealthCare is deeply committed to delivering high quality affordable care to our patients. And as part of this commitment, the Sharp Pharmacy team uses a cost based approach to review all medications for safety, efficacy, and cost. This approach has generated significant savings for our health system and for our patients, as these lower cost alternatives, including both generics and biosimilars, have reduced our acquisition costs and lower co pays and out of pocket expenses for our patients.

For example, a new drug, Usintech, is a biosimilar that the FDA has approved to be as safe and effective as the reference drug, Stelara, a brand name biologic product for treating psoriasis. And Yesintec is 97% lower than Stelara in cost.

As Andrew shared, under California law, pharmacists are authorized to substitute generic versions of prescribed medications unless the substitution. But the same state authority does not currently, include substituting biosimilars for prescribed, reference biologics like the Stelara and Yesinteq example, even when the biosimilar is FDA approved and clinically equivalent for that patient. This means that Sharp Pharmacy team must undertake additional time consuming step steps and make multiple phone calls to individual physicians, to clarify treatment plans and switch these medications. These administrative hurdles take time, physician time, away from our patients and can delay patient care.

SB 1094 removes those barriers by providing pharmacists with the authority needed to make these prescription changes to biosimilars, as we do generics, and help protect limited health care dollars for everyone.

Thank you.

Do we have anybody else? Okay. We're gonna go on to lead opposition. Two witnesses. Yes.

Two witnesses. We're doing we twos after. Yes. Thank you. Lead opposition.

Two minutes for lead opposition.

Good morning, madam chair and members. Brian Warren with the Biotechnology Industry Organization. We have a opposed and less amended position on this bill today. We'd like to thank the author and her staff for their responsiveness to our concerns, and we appreciate the amendments that are being done. However, they do not resolve our concerns.

We have we have concerns with this bill for a number of reasons. One is that we don't believe that this is scientifically justified and we believe that treating all biosimilars as if they are interchangeable undermines the authority of the FDA. The standard for approval of that biosimilar is that they are highly similar to the reference product and that they be there would be no clinically meaningful differences in the safety, purity, and potency. They are not tested for therapeutic equivalence.

That is quite literally the approval process for the interchangeable designation for biosimilars, which pharmacists can currently substitute today without any prescriber authorization.

We also believe that right now, the FDA is already taking steps to ensure more drug more biosimilars are authorized as interchangeable. They have streamlined the process, which we believe is the correct way to do it, is make it easy to get that interchangeability designation so that providers can have confidence that these can be substituted for patients without any adverse effects on their outcome on their patient outcomes.

We also believe that no one has demonstrated a need for this bill in terms of defining the barrier that currently exists. As mentioned, pharmacy substitution can already be done under existing law automatically for interchangeable products. And for non interchangeable biosimilars, it can be done with a simple phone call to the prescriber's office, which is usually a one time thing.

Pharmacists can also substitute without prescriber approval like the previous witness about from Sharp HealthCare if they are in an integrated system under authority that, exists for pharmacists already. However, the important safety standard there is that there are specific protocol that those substitutions can occur within. So it's very defined within a box, whereas this is a completely open process. Finally, our concern is that to understand the true impact on patients, you need to consider, the context of the Thank you. Oh, thank you.

Yeah. Next, two minutes, guys.

Tim Madden, representing the California Rheumatology Alliance. We are opposed to SB 1094. We appreciate the time the author staff has provided us to talk through the bill and our concerns, and our folks are reviewing the amendments. Our concerns are centered around the impact SB 1094 will have on rheumatology patients and rheumatologists' ability to provide what they believe is the best care for their patients. The conditions patients have when seeing a rheumatologist are quite unique in that there are no cures.

The most common condition rheumatology patients have is arthritis. Patients with these conditions experience chronic aching, throbbing, sharp, or burning sensations. For some patients, the pain render them renders them unable to get out of bed, go to work, or have any type of a functioning life. Treatment center around trying to find the best medication that will help the patient. This is not always straightforward and can often take months of trying different medications to find the one that works best for the patient.

One of our concerns with SB 1094 is the expansion allowing pharmacists to switch a patient from their current medication to any biosimilar. Biosimilars can be an effective choice, but every patient is going to react differently to a biosimilar and the experience of rheumatologists is there are patients who have negative reactions when switched. Reactions include a rash all the way up to a flare up, which may cause the patient's condition to revert back to the levels when they're first being treated.

A larger concern I've been told is around the multiple switching that occurs at the specialty pharmacy between biosimilars and the lack of notification directly to the physician when a switch is made. One example was a patient switched from one biosimilar to another three times during a four month period.

The physician did not become aware of the multiple switches until the patient came into the office and was complaining of a rash. The dermatologist was left with trying to figure out which biosimilar caused the reaction and then what to prescribe to get the patient back on track. The amendments outlining the analysis do include a requirement for health plans to give patients and physicians at least 30 notice

Thank you.

When a switch is made.

Appreciate it. Alright. So now we're gonna go on to Me Too's both in support and opposition. In this stage, you will state your name, the organization you represent, and whether you support or oppose the bill.

Good morning, madam chair members. Tim Taylor with the National Federation of Independent Business in support.

Thank you.

Madam chair members, John Wenger on behalf of America's Health Insurance Plans. Apologies for not getting our letter in on time, but we are in support.

Thank you.

Katie Van Dynes with Health Access California in support. We look forward to reviewing the committee amendments. Thanks.

Beth Lownowsky, the SGA of California in support. Thank you.

Matt Baque representing the Osteopathic Physicians and Surgeons of California in opposition.

Moira Topp, on behalf of Biocom, we appreciate the amendments, but we do remain opposed unless amended and look forward to working with the author.

Thank you.

Alexis Rodriguez with the California Chamber of Commerce in support. Thank you.

George Soares with the California Medical Association with the amendments outlined in the analysis. We'll be moving to neutral and thank the author and her staff for all the work. Thank you.

Good morning. Adam Quinones with California Advocates on behalf of the Family Business Association in support.

Nick Luisos on behalf of the California Association of Health Plans in support.

Good morning. Justin Fanzo on behalf of CVS in support. Thank you.

Good morning. John Sharikin with the Association of California Life and Health Insurance Companies in strong support.

Good morning. Anthony Butler Torres on behalf of the California Hispanic Chambers of Commerce in support. Thank you.

Good morning, chair and members. Allison Ramey on behalf of the Pharmaceutical Care Management Association in support.

Thank you. Seeing no other witnesses, we're gonna turn to the committee. Committee members, would you guys like to comment, Senator Strickland?

Maybe some of the opposed unless amended. I've heard a few. Can one of you step up? You know, I I the author wants to bring down cost and, you know, going into the biosimilars and and, one of the testimonies was it should be the patient and the doctor that decides, everybody wants to lower the cost.

What one, what is the amendment that you're seeking that would, get you neutral to this bill that the author because the author seems to be working with some of the other groups that get the

The amendment that we submitted Senator, thank you for the question. The amendment that we submitted was, to revert back to existing law as it relates to the BNP code section to limit pharmacies of automatic substitution to those products that have been deemed interchangeable by the FDA.

Right. And that's the amendment you're looking for? Correct. Okay. And then

And I'm sorry. Senator Strickland, just Please. So you know, just I don't know if you were here at the beginning. Yeah. But in the bill, it specifically states that a physician can always put do not substitute.

Okay.

And it's there, plain and simple.

Okay. If the

physician does not wanna substitute, the patient doesn't wanna substitute, the provider does have that ability when they write that prescription to check that box or write do not substitute.

Well, one of the one of the questions I just the the bottom line is, when it comes to biosimilars, someone testified that it could have a reverse effect, if you use one drug and even though it's a biosimilar, it could have a reverse effect on that patient. Is that often happens frequently?

I may defer to my colleague from Thank you. Dermatologist who has that.

Please. Because obviously, patient safety is a top priority. I know it is for the author as well. So Yeah. Does that happen frequently?

It I'm not sure to answer your question directly. It happens I can't give you a percentage or how often it happens, but it does and the challenge is is that every patient is a little bit different and how they react to a certain biosimilar is going to be, different. So it's challenging for them to know, if that reaction happens. So does it happen? Yes.

I've heard examples that the reactions have caused a flare up that let them go to the hospital. I've heard probably more examples where it develops like a rash, something changes. It's not quite like a full blown flare up, but there is a change. And I think the one of the frustrations is and I'll kind of speak to the senator's comment on the do not or dispense as written aspect of it because to be really frank for me, I thought that was, you know, a perfect thing.

Well, if the physician is concerned, they'll just mark do not substitute and that's the end of the conversation.

The physician described that within the biosimilar world, there might be some that are a good substitute and they want to have the ability for the patient to go on to it for the reasons that the center is talking about. But there are some that they feel are clearly not a good option. If you mark that box, it's either you're either in or you're out. You don't have

So it's all or nothing is what you're saying?

Exactly. So that's one of the challenges with that aspect of it. But Okay. Hopefully that answers your question.

Yeah. No. I appreciate that. Thank you.

Senator Menjivar. Thank

you. I'm sure I have a question for the author and then for the opposition. I'll start first with with Senator. The amendment that you took on the thirty days notice, can you tell me in real life if this bill kicks in, someone with a chronic disease has had a prescription for a while, and can you let me know at what opportunity would the physician be able to put do not substitute? Is it anytime it gets renewed or

Any of the initial Yeah.

Oh, yeah.

No. Anytime you write a prescription, you can always put do not substitute. And I also just wanna remind people that right now that happens with generics. So I prescribe a medication, specific name of a medication, based on the pharmacist, the particular insurance company. There may be something that costs lower, so it'll be switched at the pharmacy level.

And the and at that point, with that particular medication so the fact that in this bill, we are informing, providers as much more than what I get right now with generics, I don't get any kind of, notification. I find out when the patient says, can you refill this? And I'm like, what is this? And then I realized that that had been switched over. And so the concern of of side effects, low, same thing with generics as well.

So, like, my prescription is just I get refills, like three to four refills, and I just go in and click a button for a refill. At that moment, though, does a physician gets gets notified? So the

physician would be notified when it is initially switched over. Okay. If the patient has any concerns or issues, of course, they'll contact at the provider's office and they can then reissue another prescription and say do not substitute.

And given the thirty day notice, a physician will have the ability at that moment if they want to Stop it. Great. Yeah. Great. And doesn't it already exist if my coverage I change insurance and I'm on a medication right now and I change my insurance that there perhaps my medication would have to be changed as well?

Yes. So that already exists today. So it's similar to the scenarios that that you're Similar

to the scenarios that you have with your generic meds.

Okay. And then to opposition in rheumatology, talk to bar arthritis. It's a long, you know, term illness. I'm wondering if the thirty day notice is not enough time to adjust, if need be, for the patient to talk to the physician if sad medication is not gonna work for them?

Since it's a good question. And with since that's a part of the amendments that we're just put in the analysis, I'm getting that feedback right now. In the spirit of being corrected by my client, I do believe it's a step in the right direction because it kinda gets back to the place where it allows for that interaction between the physician and the patient to understand, okay, is this the right way to go?

And the thirty days is a great window to then say either do not substitute or there are other some provisions under existing law that are some exceptions that would allow the patient to not have to move on to that medication. So I think that's a great setup.

But once again, that's in the health and safety code section and it applies to the health plans. So, for this committee in the BNP code section, that is not a part that applies to pharmacists.

Got it.

So, there's no advanced notice to a physician if a pharmacist is going to make that switch. Okay.

And also, just for clarification, health staff just reminded me that the thirty day is already what Medicare does. So for those that are deemed interchangeable, so we are just aligning And aligning. With what is already in practice.

And, Senator, my last question is during those thirty days or any does a patient have the ability to reject and say, I don't wanna switch over?

Oh, yes. They do. Okay.

Thank you.

Would anybody else like to comment? Senator Choi.

Thank you, chair. Maybe it's all redundant, but I wanna make sure that when doctor prescribes do not switch, that means you already know about the reactions the biosimilar may cause to the patient that you know of.

Yeah. So a doctor can put do not substitute, do not switch for a variety of different reasons. If you're doing it initially, it may not be because you know of a reaction to that particular patient because that patient has never been on that medication. You may specifically like a certain type of medication, brand name medication. So there's a variety of different reasons.

So when you do that, does insurance company have to okay

your prescription Yes. Within thirty days?

Yes. For

If you say do not substitute and it is on the insurance formulary, then they have to go with what you have prescribed.

So that is the step every do not substitute will have to go through for the approval from the insurance company. So that means that during that time, whatever the the thirty days are long time, when I need the medication today, then I have to wait the thirty days.

So that is with any medication. So if I write

Any medication, thirty days.

I write a prescription for something that your insurance company does not cover and I click do not substitute, then you would have to pay out of pocket for it. And some patients will do that. If if they say, I want brand name even though it's not covered, you can get the medication you would have to pay out of pocket. But as of right now, biologics and bios or interchangeable biosimilars are on many forms.

So if I pay out of my pocket for now because I need the medication, then after insurance company agrees to that, will they reimburse me?

If it's on the formulary.

For the brand name.

Because you you marked her as a do not substitute and eventually, insurance company agrees to that, to your order, doctor's order, not to substitute, will they reimburse me the difference that I bought paid out of my pocket because of urgency?

For the brand name.

That is probably something that that particular individual would have to take up with their insurance company.

So your bill is not clear about that?

This is not It's not this is not about the bill. Like, what you're asking isn't What your question is about process and procedure, this bill is very specific about the label.

Okay. What was the, the amendment, the committee, the proposal you accepted? Can you elaborate what amendment was exactly?

So there's a whole slew of amendments. I think it's probably in your committee analysis.

It's specifically item number seven in the, background document, and we're happy to go over.

The author is has accepted adding the word safe to legislative intent provisions, clarify that substitution for an alternative biological product by a pharmacist is a biosimilar to or interchangeable with the prescribed reference product, require the Board to maintain a link to the purple book rather than a list of products FDA has determined or interchange of products the FDA has determined are interchangeable, define reference product as having the same meaning as federal law, specify for purposes of requiring an enrollee to try the therapeutical equivalent generic biosimilar or interchangeable biological product that the plan must provide at least thirty days advance notice to the enrollee and their prescribing provider prior to substitution and authorizes the enrollee or their provider to request an exception to the requirement to try an alternative product, specify that a plan is not authorized to alter or issue a prescription and make various technical and conforming changes.

So those are the amendments.

Thank you for that clarification, Chair. I have one more question. Since you're an authorized doctor, maybe you can tell. Obviously, we are from the insurance company's point of view is they are trying to save the cost and the money for the cost of the drug and from the consumer's point of view is that not only less money but effectiveness of that drug. And when a biosimilar is approved by FDA, so that means the effectiveness of that biosimilar is same or very close to the brand name.

Typically, how would you say from the doctor's point of view, similars are how effective they are. If no difference, why we should argue about this? Any any, similar or brand name should work. But, what I'm hearing is that side effects of the caused by biosimilars are significant. If the formula is very similar, why the similar the copies of the medication will cause that kind of a side effects?

Yeah. So I think what we heard are potential side effects, and you can have potential side effects with any medications, whether they're brand name or generic. The ones that were listed were actually considered very minor side effects, rashes, things like that. You can get that with any kind of medication that you're on. But to your point, when you listen to both sides, it's somewhat confusing.

Right? And I think a lot of the confusion has occurred because of what has happened at the federal level. It would I don't think anyone would argue that biosimilars are safe and effective. You have to be safe, show efficacy and effectiveness in order to get FDA approval to be a biosimilar. The confusion has come in with the separate category that Congress put in a while ago that deemed some interchangeable.

And in 2024, I believe, there was a draft guidance that came out from, Department of Health and Human Services that said one thing. And since then, the FDA has really looked at biosimilars, those that are interchangeable and those without the designation, and they've looked at the studies that they required for getting that diagnosis and they've realized that pretty much biosimilars are just as effective whether you have that specific interchangeable diagnosis or not.

They have actually introduced, legislation and it's also in your, analysis to eliminate this confusion, that would eliminate the statutory distinction between biosimilars and interchangeables, to help states and to help out, to help lower cost, within the healthcare system because there is that realization that these are effective, these are safe, whether you have that designation or not. And so this is what this bill basically says is that they're the same.

This is what the FDA is finding out and they're changing their policies, and we need to ensure that we're able to provide this for our patients, but also to ensure that, we're lowering the cost of health care.

Thank you.

Okay. Thank you so much.

Senator Nilo.

I want to clarify some of that previous conversation and questions that I had in reading this. We have three categories and there may be not as much a distinction on the second two based on your prior comments. But first of all, there's the the drug itself Which has gone through the FDA for initial approval. There is a there are biosimilars which are roughly equivalent to generic drugs. And then there are interchangeable, biosimilars.

And I think I heard you say that's a designation from Congress Or FDA?

Congress.

From Congress. So FDA doesn't recognize the difference between a biosimilar or an interchangeable biosimilar.

The FDA initially did recognize a difference and stated that if you're a biosimilar, you have to kind of meet this threshold to get FDA as a biosimilar.

And if you want that interchangeable definition, you would need to go through and do some more more studies, comparative studies, and over time, they have started to decrease the number of studies that are required, because what they've looked at with the data is that it's pretty much the same, and requiring these extra steps does not, they have not necessarily, like, not approved a whole slew of biosimilars to become interchangeable, which is why in order to kind of fix that, they can't just get rid of the designation interchangeable themselves because they didn't create it, which is why I just stated they have this new legislation that they've introduced in 2025, a part of their legislative priorities.

And all of these are manufactured by different companies. There's a company that makes the basic drug itself, and then there's a whole bunch of companies that make variations of it. Well, I won't use that word. Make biosimilars or interchangeable biosimilars, whatever they are, the generic equivalent of that drug. Now, presumably, physicians know this.

They're familiar. I'm I'm assuming, and tell me if I'm correct in assuming it or not. They are familiar with the, drugs that are offered by the various companies, both of the, the the basic drugs drug itself as well as the biosimilars whether they're interchangeable biosimilars or not. They're gonna know those drugs, the companies that make them, and what what the the doctor's perception is the effects that they have. Is that a safe assumption?

So because biologics and biosimilars are extremely difficult to manufacture, they're not like the other medications that we use where you've got 20,000,000, 11,000 versions of one, brand name. Most physicians who prescribe these medications, and not a lot of physicians prescribe biologics or biosimilars, are aware of the fact that there are biosimilars or interchangeable biosimilars, which is why we have given them the authority to say, we wanna stay with the brand name, biologic, or allow them the ability for their medication, their original prescription to be substituted.

Or they could specify a specific

They could specify.

Of biosimilar or interchangeable biosimilar.

They could do that as well.

So it would seem to me that if this bill passes, physicians are gonna know the allowance as it's been changed by the bill. And the physician then can prescribe either the brand name drug itself or a specific biosimilar or a specific interchangeable biosimilar or if the physician believes that there isn't a significant difference for that particular patient, prescribe the drug and allow for the pharmacist to make a decision.

That is correct. We do not take away physician discretion nor do we take away the conversations between patients and, and their physicians to make a decision about what medication would be best for them.

Thank you.

Thank you.

Senator Archuleta.

Thank you, doctor, for presenting the bill. And as as I'm hearing all this, I think it's a it's a bill that, is saving money for the consumer. At the same time, it's bringing the relationship with the doctor and the pharmacy even closer because now you have and the patient all working together to be able to say, doctor, I saw this on TV. I want this. Well, if that's what you want, that is your choice.

And or you'll come back and say, for the price, I think this will this will suffice and or the pharmacy when they receive it and the doctor says nothing, then the pharmacy will be able to say, did you know that you can save money using this? And again, it goes back to the choice of the patient. So because it all comes together, I think it's a good bill, and I would like to move it at appropriate time.

Thank you. Seeing nobody else, I do just want to highlight, I want to appreciate the author bringing this bill forward, but I also want to just provide some clarity. In the backgrounder on this particular bill, page nine of 14, it was very clearly stated FDA guidance on biosimilars and interchangeability addresses the evidentiary standards for product approval, not pharmacy level substitution, which FDA has stated is outside the scope of its approval authority and instead governed by state pharmacy law.

So I I do wanna flag that for everybody just on confusion. The issue also of ensuring that this is safe and affordable medication is one that I think all of us care about, especially in the height of our affordability crisis.

And I also wanna highlight the fact that what we are trying to specifically talk about is last year, the FDA itself proposed to eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products, a move that would deem all approved biosimilars as interchangeable. This is the reason why there was so much confusion over the course of years. And again, this bill is just to level set and correct that at the state.

The author has also shown a commitment to work with stakeholders through her proposed amendments, and I do support her having the ability to continue doing the work. At the end of the day, it does benefit the consumer.

As far as the fears of, you know, how this potentially harms anybody, I do also wanna flag that biosimilars can only happen when a patient is prescribed a reference drug, and they will benefit from the cost savings. So again, we are taking safety into consideration. We're taking what is happening at the national law and efforts there to really just correct what is happening here and confusion and reduce costs. So with that, I have an I recommendation, but, Senator, would you like to close?

Thank you. Wanna thank the committee for all of your your questions. This is a very important bill dealing with a very important issue. Wanna thank again the committee staff and also, the health committee staff on this bill. Wanna thank all those who came out and spoke in support and opposition.

But at the core of this bill is about affordability and access, which are key components for adherence to any treatment. It is about making sure Californians can get the care they need without having to choose between their health and their financial stability. We have many safe, effective, lower cost alternatives to staggering, expensive biologics available today, but we're not using them to their full potential.

This bill offers several practical ways to encourage biosimilar use to bring down the cost and inject more competition into a system that pharmaceutical manufacturers have controlled for far too long, doing this without compromising patient safety. Four out of ten Californians are struggling with medical debt.

Six out of ten Californians report skipping medical care due to cost. And seven out of ten Californians are more worried about medical bills than the price of housing or utilities. With statistics like these, we need to get serious about addressing the rising cost of health care, And with that, I respectfully ask for an aye vote on SB 1094.

Thank you. Thank you. We have a motion by Senator Archuleta. I reco from the chair. Let's do a roll call.

Motion is to pass as amended to Senate Health Committee. Wahab.

. Aye.

Sure.

Aye.

Wahab, Aye, Choi

Choi, Aye, Archuleta.

Archuleta, Aye, Arreguin.

Arreguin, Aye, Caballero.

Aye.

Aye.

Aye.

Caballero, aye. Grayson?

Aye.

Aye.

Grayson, aye. Menjivar,?

Menjivar, aye. Nielo?

Nielo, aye. Smallwood Cuevas. Strickland?

Aye.

Aye

Aye.

Strickland, aye. Umberg?

. Umberg, aye.

Alright. That bill is 10 to zero. That bill is out. Thank you, everybody. VPET is adjourned.