Biosimilar Bytes: Alvotech Biosimilar News and 6-Month Ustekinumab Switching Outcomes

Alvotech has a new vedolizumab BLA and new marketing partner, and Stelara biosimilars produced equivalent clinical outcomes to the reference product over 6 months of treatment.

Alvotech’s Second Application for Vedolizumab Biosimilar and New Marketing Partner

Alvotech announced that the FDA has accepted its 351(k) application for a prefilled syringe and autoinjector formulation of vedolizumab. This product, dubbed AVT80, follows Alvotech’s previous submission of an FDA application for AVT16, the intravenous formulation of the same integrin inhibitor. According to a company Email to BR&R, Alvotech utilized two separate compound designations for this Entyvio biosimilar, because the reference compound was approved under two separate biologic licensing applications. Teva is the marketing partner for both formulations. The second vedolizumab biosimilar application, submitted to the FDA by Fresenius Kabi and Polpharma, was for the intravenous formulation only.

In separate Alvotech news, it has signed an agreement with Lotus (and its US-subsidiary Alvogen) to market AVT34, a proposed duravalumab biosimilar, and AVT 87, a proposed emicizumab biosimilar. Duravalumab (Imfinzi) is a PD-L1 inhibitor, with multiple cancer indications. The major patents for this product may not expire until after 2035. Emicizumab (Hemlibra) is a bispecific factor IXa- and factor X-directed antibody to prevent bleeding episodes in patients with hemophilia A. First marketed in 2017 as well, this product’s main patent expires in 2032, according to sources. The agreement is not exclusive, and may result in Alvotech also marketing these products in the US. In addition, it applies to selected Asian markets.

Stelara Biosimilars Work Well in Italy, With Little Switching Back

An Italian study published online in Clinical Gastroenterology and Hepatology found that switching from Stelara to ustekinumab biosimilars resulted in equivalent success rates (92%–93%) in 337 adult patients with Crohn’s disease after 6 months of treatment. The study group was compared with 125 patients who continued to take the reference product. Only 1.2% of patients switched back to the reference product. The authors noted that longer-term data would tell a more comprehensive story for this chronic therapy.

This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.

The Bona Fide Marketing Standard and What That Means for Biosimilars and Generics

Teva received an appellate court ruling suggesting that CMS did not have authority from Congress to define a bona fide marketing standard for its IRA Medicare Fair Price negotiations. How does this relate to products targeted for IPAY negotiations and biosimilar competitors?

This week, Teva received an appellate court ruling on the IRA Medicare Fair Price (MFP) question as to whether a generic drug (or biosimilar) is to be considered a “bona fide” marketed product. This gets to the very heart of whether the reference product or originator brand is eligible for the MFP IPAY negotiations in the first place.

In Teva’s case, the DC Appellate Court ruled that the challenge to the Centers for Medicare and Medicaid Services definition of bona fide marketing is valid. In its decision, the Court stated, that CMS will consider a generic as marketed “only when the manufacturer engages in ‘bona fide marketing.’ Teva says both rules exceed CMS’s statutory authority and that the Negotiation Program deprives it of a protected property interest without due process. The Government responds that the IRA bars courts from reviewing Teva’s statutory claims. Teva’s challenge to the ‘bona fide’ marketing requirement, however, is ripe for review.”

Whereas the appellate court did not rule on the merits of Teva’s challenge to the definition, it sent the question back to the District Court with the explanation that the IRA legislation did not give CMS the authority to make this determination.

IRA MFP Controversy From the Beginning

CMS decided that ustekinumab should be eligible in the first round of IPAY negotiations, despite the large number of approved biosimilars scheduled to launch prior to the implementation of its MFP-negotiated price (January 1 2026). In November 2025, CMS decided to delist ustekinumab, in the face of active biosimilar competition, though the MFP pricing ($4,695 per 30-day supply) will apply through January 1, 2027. The current WAC cost for Stelara is down to less than $500 per month. In other words, CMS is overpaying (by a lot) this year for ustekinumab.

In the case of etanercept, it was also included in the first round of Medicare price negotiations, despite two US FDA approved biosimilar products but no expectation for launches before 2028, owing to patent extensions of dubious justification. For Enbrel, the implementation of MFP discounts makes a lot of sense, despite the likely lost future revenues by the biosimilar manufacturers.

This points to the unpredictability and challenges of evaluating potential patent settlements and launch agreements with reference manufacturers. We are already seeing the potential for this to affect Keytruda, Opdivo, and other big-ticket biologics with significant upcoming biosimilar competition.

What Is Bona Fide Marketing?

Another interesting point related to the bona fide marketing requirement is that even if a biosimilar product is approved and marketed, there is no guarantee that the manufacturer will enter into large marketing programs as are commonly seen for reference or branded products. Typically, especially on the generic side, marketing budgets are relatively low end; the manufacturers may rely on automatic substitution heavily to gain prescription volume. This consideration seems to be outside of CMS’s thought process. Personally, I’ve seen only limited traditional marketing efforts on the part of biosimilar manufacturers several specific products.

This brings us back to the original question of whether CMS has the best standard for gauging the expected launch date of a generic or biosimilar at the time it produces its list of IPAY targets for the current year. We’ve seen no evidence that there is a consistent bar or protocol through which these decisions are made. Yet, these decisions may be crucial for prospective biosimilar manufacturers and for CMS itself—biosimilars with adequate competition will always produce greater discounts and lower prices than IPAY negotiations. Notwithstanding the ability of CMS to delist in the future a product that has been exposed to biosimilar competition, if it doesn’t change its view towards eligibility of reference products, CMS will continue to waste time negotiating pricing on products that will be delisted within a year of implementation. More importantly, it would lose the opportunity to save billions of dollars from biosimilar competition for the year before delisting. And isn’t saving money what this exercise is all about?

US Humira Sales Overwhelmed by Biosimilar Competition

Adalimumab biosimilar utilization account for more than 80% of the drug category, as AbbVie’s Humira revenues dry up.

Although the numbers are hard to come by, it seems apparent that adalimumab biosimilar sales have pounded the reference product Humira into submission through the second quarter of 2026. AbbVie announced Humana net revenues of only $425,000,000 for the second quarter, another massive drop of 47% versus the same quarter of last year.

The utilization numbers involving biosimilar forms of adalimumab have been complicated by the significant sales of private-label versions through the big 3 PBMs and their subsidiaries. Based on reporting by IQVIA, not all of these private-label prescriptions are reported directly; however, the Pharmaceutical Resources Group recently indicated that the total share of AbbVie’s Humira prescriptions is now below 20%. This roughly aligns with the latest earnings report from AbbVie, showing titanic reductions quarter over quarter. Prior to biosimilar competition in 2023, AbbVie netted $18.6 billion in US sales; it is on track for closer to $1.5 billion through the end of 2026.

As pointed out by Bryce Platt at Drug Channels Institute, and by us in the past, the lowest-price discounting for adalimumab biosimilars has not guaranteed increased preferential coverage for utilization. Instead, private-label contracting by the biosimilar manufacturer seems to move the needle more significantly.

As Skyrizi and Rinvoq Fill the Revenue Gap, Do Health Plans Further Restrict Their Use?

In any case, no one is feeling sorry for AbbVie these days because of the bloated numbers being posted for Skyrizi and Rinvoq sales. These are easily taking up the slack for the hole created by cratering Humira revenues. As a related question, it would be interesting to better understand whether health plans have now firmly decided to require a low-cost adalimumab step prior to covering either Skyrizi or Rinvoq for patients with the dozen or so immunology indications that they are approved to treat.

It’s not a simple question. For example, UnitedHealthcare’s medical coverage policy for Skyrizi in plaque psoriasis requires use of “documentation of moderate-to-severe disease plus failure of at least one conventional systemic therapy (methotrexate, cyclosporine, PUVA, or acitretin) OR prior treatment with any targeted immunomodulator like TNF inhibitors or other biologics.” It also varies by indication: CIGNA’s coverage policy for Skyrizi and Rinvoq in Crohn’s disease and psoriatic arthritis lists it as a preferred step 1 agent, along with adalimumab, Tremfya, Taltz, and ustekinumab biosimilars, whereas Rinvoq is nonpreferred (where patients are directed to adalimumab specifically). This is accompanied by many specific criteria allowing for exceptions to the coverage policy. Then, of course, is the difference between medical coverage and pharmacy coverage policies for these mostly self-administered products.

From a quick scan of these coverage policies, it does appear that the adalimumab and ustekinumab biosimilars have been firmly set as first-step options among biologics. The question of whether their own use require fewer prior authorization criteria (or even no prior authorization scrutiny?) has not been answered. It is extremely important to point out that, as inexpensive as adalimumab biosimilars are today, and as easy as they are to access, these are biologic agents with potentially serious side effects and complications. They are not for every patient, and therefore, prior authorization criteria should probably remain in place, even as they grow in utilization and remain inexpensive.

In Other Biosimilar News

According to an agreement between Sandoz and Shanghai Henlius, Sandoz will have global commercialization rights (outside of China) to up to 10 potential biosimilar candidates being developed by Henlius, including three announced agents: evolocumab (reference product, Repatha) for the treatment of hypercholesterolemia, belimumab (Benlysta) for the treatment of systemic lupus, and cetuximab (Erbitux) for the treatment of colorectal cancer.

340B Pilot Program Could Be Big Boon for Biosimilars

The 340B Rebate Pilot Program could give biosimilar makers a needed boost, as they lose revenues to the profit incentive of eligible covered entities.

The 340B program has been a barrier for biosimilar products being dispensed in outpatient facilities. Forbes sites that branded drugs account for approximately 90% of 340B pharma sales, compared with 78% of non 340B drug sales. As we reported earlier this year, there is a significant reduction in biosimilar use among 340B eligible entities. This makes sense because the entity can purchase the drug at the 340B price and get reimbursed by payers at the far higher WAC price. This has been a proven profit driver for health systems and hospital networks.

However, if the covered entity is forced to pay full price upfront for a biologic product with biosimilar competition, it may be much more inclined to seek out the lower cost of the biosimilar. This would make more sense than to take on the risk of obtaining a rebate later, if the entity is found to be truly eligible for the 340B discounted purchase. Under the new Health Resources and Services Administration’s (HRSA’s) 340B rebate pilot, the rebate to make up the difference between the WAC cost and the 340B price would only be paid retrospectively, after approval of the transaction.

Hoping to implement the pilot on January 1, 2027, HRSA will first apply it only to products that are subject to existing Medicare maximum fair price (MFP) agreements. Therefore, the number of biosimilars affected over the short term is very low, really only to adalimumab and ustekinumab, which are generally available as self-administered products. Yet, the breadth of the program could be expanded with the coverage of additional MFP-eligible products in the future. This can certainly have implications for the next generation of oncology biosimilars, such as Keytruda and Opdivo, as well as any other infusible biologics that are to face biosimilar competition.

On the other hand, a bipartisan legislative proposal introduced on August 5 by Senator Tammy Baldwin (D-WI) and Senator Jerry Moran (R-KS) would retain the upfront discount that 340B-eligible entities currently utilize, and stop the HRSA pilot within a year of implementation. This would not significantly change the outlook for biosimilars should these heavily lobbied proposals find their way into signed law.

The objective of any 340B reform is to wrangle an out-of-control pharmaceutical financing program, protect legitimate higher-price sales by the drug industry, and reallocate the program’s true benefits back towards safety net institutions. For-profit entities that were squeezing profits from the 340B program can simply purchase lower-cost biosimilars from the outset, and benefit from their deep savings instead.

MFP Agreements Don’t Guarantee Better Patient Access

A study by IQVIA finds that first prescription rejection rates were unchanged for the first MFP negotiated drugs after implementation in January.

A notable study by IQVIA found that for the first drugs subject to Medicare maximum fair price (MFP) agreements, initial rejection rates were not significantly lower than before the new prices took effect in January 2026.

One of the main stipulations of the MFP agreements was that if the reference drug manufacturer signed an MFP agreement, Medicare Part D drug plans and Medicare Advantage plans would have to cover the drug on their formularies.

Enbrel and Stelara Rejection Rates

Enbrel and Stelara are the two Part D drugs of interest in this first round of Medicare MFP negotiations. Enbrel has no current biosimilar competition (though 2 approved products), and Stelara has plenty of it.

These two drugs comprise the immunology sector of the first 10 drugs subject to MFP. According to the IQVIA data, the initial rejection rates for those new to the brand were 59% for the first quarter of 2026. When looking forward 30 days, the average rejection rate on appeal was 22%. In the past 5 years, the initial rejection rates ranged from 61% to 73%. IQVIA did not break down the rejection rates for the two individual biologics.

In their post, IQVIA said, “Expectations for Medicare drug price negotiation to improve patient access have yet to come to fruition. Even more concerning, additional future IPAY-selected drugs are in the immunology and oncology therapeutic areas and other therapeutic areas with similar costs and treatment complexity, facing similarly high levels of payer control.”

The Result of Heavy Biosimilar Competition?

Granted, both etanercept and ustekinumab are unusual products, in that they are both subject to heavy competition from other agents within the same or similar drug categories. In fact, the MFP for Stelara is not competitive with several ustekinumab biosimilars on the market today. The existence of over 10 adalimumab biosimilars at deep discounts would be a highly attractive prior step before approval of either Enbrel or Stelara. Therefore, it is unlikely that payers will significantly change coverage policies to improve access to these two agents under current conditions.

As more Part B medications are subject to MFP negotiations, patient access may change somewhat for those particular drugs. However, one must remember that patient access improvement was not the primary goal of Medicare MFP negotiations under the Inflation Reduction Act. The real goal was cost reduction for the Centers for Medicare & Medicaid Services.

As we can see, cost reduction may not equal better patient access, even if deep price reductions on biologics are available on direct-to-consumer sites because of relatively high patient out-of-pocket costs. Therefore, this finding is not surprising. We saw the same lack of effect when the adalimumab biosimilars were first introduced in 2023: Much lower costs didn’t result in prescriptions to patients; only formulary policy changes did.

Instead, I tend to view IQVIA’s study as more supportive of a 360-degree view of the effectiveness of biosimilar competition for these two medications.

Biosimilar Bytes: Biocon’s Yesafili Launches and Dr. Reddy’s Rituximab Biosimilar Is Approved

Biocon announced the launch of its Yesafili biosimilar, in competition now with Pavblu, for the aflibercept market. Dr. Reddy’s and its marketing partner Fresenius Kabi have received FDA approval for its rituximab biosimilar.

Biocon Begins Marketing Its Aflibercept Biosimilar Yesafili

Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon Limited, said, “The commercial launch of Yesafili in the United States is an important milestone in our efforts to improve access to high-quality biosimilar medicines. It strengthens our presence in ophthalmology and reflects our commitment to making advanced treatments more accessible and affordable for patients around the world.”

The second aflibercept biosimilar has reached the US market, as Biocon Biologics announced the launch of Yesafili. Initially approved in May 2024, along with a slew of other aflibercept biosimilars, launches were delayed by settlement agreements with the manufacturer of the reference product, Eylea.

Pricing information was not reported for Yesafili. Significant sales volume of the first marketed aflibercept biosimilar, Pavblu, was achieved with a relatively small wholesale acquisition cost discount (–16%). Amgen, in its second-quarter 2026 earnings, reported $280 million in US sales, putting it on pace to be the first billion-dollar biosimilar. It has largely driven Amgen’s overall biosimilar revenues, which are up 29% from the same quarter in 2025.

Dr. Reddy’s Readying Rituximab Biosimilar for Launch with Fresenius Kabi After FDA Approval

On August 1, 2026, Dr. Reddy’s Laboratories received FDA approval for its rituximab biosimilar. The brand name and nonproprietary name suffix were not announced at the time of posting.

Dr. Reddy’s entered into a commercialization agreement with Fresenius Kabi to market the monoclonal antibody biosimilar in the United States.

The agent was known as DRL_RI in clinical trials, is already commercialized in the European Union in the United Kingdom. It is sold under the brand name Ituxredi in those markets. A launch date has not been announced for this fourth rituximab biosimilar approved by the FDA.

Currently, two biosimilars (Truxima and Ruxience) lead the rituximab category, each with 35% market share by volume, based on IQVIA data.

Are Biosimilar Patient Copay Assistance Programs Lacking?

Our survey found that 87% of biosimilar products were associated with patient copay assistance programs that cut out-of-pocket costs to $5 or less. Physician perceptions of important financial assistance differences between biosimilars and reference products seem generally unfounded.

The newly published edition of the Samsung Bioepis Biosimilar Market Report indicates that with few exceptions, biosimilar competition has driven average sales prices (ASPs) on the medical side by more than 60% for products available for at least three years. This ranges from epoetin alfa at -37% to rituximab at –81%. On the pharmacy benefit side, adalimumab wholesale acquisition costs are down more than 80% for most product offerings relative to the original cost of Humira.

Biosimilar Patient Copay Assistance Programs

Success in driving down costs also means less net revenue earned from individual products. This could influence the willingness of manufacturers and their commercialization partners to offer a suite of services to patients and physicians through financial assistance programs and hub programs for handling prior authorization and reimbursement coding questions.

Even at these great discounts, the monthly copay costs to patients would be hard to bear and may be unsustainable for some extended periods of time. I have reported on this problem with respect to direct-to-consumer access for specialty brands and biosimilars. It is the reason why patient copay assistance programs are so widespread across the pharmaceutical industry, particularly for expensive biologics.

Most in the biosimilar business had considered a robust patient copay assistance program and hub services program, matching that of the reference manufacturer, to be the cost of entering the market. The reference product generally had multiple service offerings to maximize prescriber comfort to optimize utilization of their products. If physicians, who sometimes rely on this suite of services, were given a choice of a lower-cost biosimilar with fewer services and the standard reference product offering, it would make them less willing to adopt the biosimilar.

In the last couple of years, I’ve been made aware of some rumblings in the provider community that manufacturers were in fact cutting back on their biosimilar patient copay assistance programs and hub services offerings. In a market research project I worked on for an upcoming publication, some dermatologists, rheumatologists, and neurologists brought up this perception, particularly for patient copay assistance programs. As a result, BR&R conducted a quick survey of manufacturers, based on their website resources, of their biosimilar copay assistance programs.

For standardization purposes, we assumed an adequate program to be one resulting in monthly copays of $5 or less for commercially insured patients, independent of the duration of access to the program. Of course, the overall impact does not consider copay maximizers or copay accumulators from health plans.

How Many Manufacturers Don’t Have Biosimilar Patient Copay Assistance Programs?

As of July 24, a total of 68 biosimilars were marketed; we counted denosumab biosimilars as a single molecule, despite having two brand names. We then removed insulin biosimilars from the survey: They each offer a form of copay assistance, with $35 monthly copay limits. Much of this was the result of government pressure. That brings the number of eligible surveyed biosimilars down to 63. Eight or 13% were without copay assistance programs. There were some interesting caveats for those lacking these packages.

Recent Biosimilar Launches

It takes many months to fully develop a launch plan for any pharmaceutical. Generally, a product launch would not occur if all the ancillary services were not in place and ready for immediate use. For Biocon Biologics, which launched its denosumab biosimilars (Bosaya/Aukelso) in April 2026, its website indicated that its patient copay assistance program would be “coming soon.” Gedeon Richter and Hikma’s denosumab biosimilars Enoby and Xtrenbo were launched in January this year, but do not any copay assistance program associated with them.

Bio-Thera Solutions’ bevacizumab biosimilar Avzivi likewise does not have a patient assistance program. Its commercialization partner, Sandoz, does not list it among its Sandoz One offerings.

Bio-Thera and its commercialization partner Hikma do not have a copay assistance program for its Starjemza ustekinumab biosimilar. It is the only ustekinumab program lacking copay assistance.

Low-Cost Products

Nypozi, a filgrastim biosimilar by Tanvex BioPharma and commercialized by Cipla for more than 6 months, has no such services listed. Pfizer does not list a patient assistance program for Retacrit, its epoetin biosimilar. These are the least costly drug categories (outside of insulin) overall. The ASP for epoetin products is approximately $7 per 1000 units. For filgrastim, prices for the three least expensive biosimilars are $107 to $133 per 480 mg.

Discontinued Programs

In only two cases did a program exist but be discontinued. For Boehringer Ingelheim’s Cyltezo, the program ended July 15, 2026. Quallent, which sells a private-label version of this adalimumab biosimilar, claims to have a copay assistance program, but the website listed only terms and conditions, without an opportunity to enroll. Perhaps, this is in the process of rolling out in the transition. Until then, it is the only adalimumab biosimilar without a copay assistance program.

Byooviz is Samsung Bioepis’ ranibizumab biosimilar, originally in partnership with Biogen. Biogen included Byooviz in its patient assistance offerings, until the partnership ended. Harrow took over US commercialization for the biosimilar but has not unveiled a patient copay assistance program for it.

What About the Private-Label Biosimilars?

The private-label distributors add an interesting aspect to the mix, as we do not count their products as separate from the biosimilar parent. Yet, there is some interesting nuance in this area.

For example, OptumRx’s specialty distributor Nuvaila has a separate site for adalimumab-atto’s copay assistance, but it links back to Amgen’s own patient assistance site. Patients needing copay assistance for another adalimumab, Sandoz’s Hyrimoz, can access it through the Sandoz One Source, but the private-label version through Cordavis also has its own website. Finally, Cordavis, which also distributes a private-label version of Samsung Bioepis’ Hadlima, offers patient copay assistance, as does Samsung’s marketing partner for Hadlima, Organon. As mentioned above, Quallent also claims to offer such a program for its Simlandi private label (Teva provides one for the Simlandi brand), but this seems to be a terms sheet without access to online enrollment.

The Take Aways

Generally, the marketed biosimilars have patient copay assistance programs but the greatest variability seems to be associated with companies recently entering the US market or where product costs are the lowest.

Only 13% of marketed biosimilars are currently without qualified patient assistance packages. In terms of these financial assistance programs, physicians who believe that biosimilars manufacturers are lacking these offerings seem to be off base. We do not know if they are similarly incorrect about other services, like eligibility verification, prior authorization assistance, and handling returns. We may investigate the availability of these hub services in the future.

A slew of new biosimilars are expected to be launched in the next 12 months, including those in the aflibercept, denosumab, golimumab, omalizumab, and pertuzumab categories. We’ll have to watch closely.

Trump Tariffs on Generics and Biosimilars: Utter Nonsense or Just Plain Stupidity?

Trump’s desire to remove a drug tariff exemption for generics and biosimilars produced overseas is ill-conceived and truly damaging to these low-margin industries.

The Trump administration seems to think that making generics and biosimilars more expensive to the health system and consumers alike is a great idea.

On July 21, President Trump posted on social media that he intends to remove an exemption for generic drug makers from pharmaceutical tariffs and place a 100% tariff on these products in 2028. The Trump tariff would rise to 200% if manufacturers do not start producing these drugs on US soil by 2029. The Administration’s definition of generic drugs includes any nonbranded products, and biosimilars are therefore part of this category.

The Supreme Court ruled that the administration cannot legally usurp Congress’s authority to apply taxes or tariffs for arbitrary purposes. This action would not only be arbitrary but damaging to the very foundation of the biosimilar and generic industries.

The reason for the existence of generics and biosimilars is to provide lower cost pharmaceuticals to patients, payers, and the health system in general. The basis for lower costs for generics and biosimilars is competition, not decree. If a legitimate business case could be identified to support the implementation of these Trump tariffs, a portion—if not all—would be passed onto payers and consumers, thus raising the net price of generics and biosimilars. The administration seems to ignore this basic business practice.

Generic Drug Margins Already Extremely Low

We have reported that the generic manufacturing industry suffers from low margins, which have reduced production and contributed to drug shortages in the US. A substantial tariff on these medications will initiate discussions in the boardroom as to whether their falling profit margins justify the building of US-based facilities just to avoid the additional tariff costs. Some, if not many, manufacturers will answer this question negatively.

Cutting Into Biosimilar Development

On the biosimilar side, where margins are greater but revenues may still be lower than expected for some biologics, the Trump tariff will counter some of the legislative proposals intended to streamline biosimilar development that are just now moving through Congress. Furthermore, the initiative will further threaten our ability to shrink the biosimilar void, and discourage future biosimilar development.

Removing an exemption for generics or biosimilars on a more general pharmaceutical tariff is ill-conceived and short-sighted. Certainly, no Congress that is actively trying to amplify biosimilar competition and reduce development costs would agree that tariffs of this nature justify the risks.

This is a terrible idea, and it might be further evidence that someone needs to monitor the president’s social media posts before they are sent.

In Other Biosimilar News

A real-world postmarketing study of Samsung Bioepis and Harrow’s Byooviz confirmed its associated clinical outcomes were equivalent to those of the reference product Lucentis, according to Korean researchers.

Interim results of this open-label observational study were presented at the annual meeting of the American Society of Retinal Specialists, July 15–18, in Montreal. The interim data reported results on 298 patients treated from May 2022 to May 2026. One hundred eighty-two participants did not have previous VEGF inhibitor treatment, and 116 were switched from the reference product. After 24 weeks of treatment, Byooviz’s efficacy, in terms of best-corrected visual acuity and central subfield thickness, was not significantly different than Lucentis, without new safety concerns. Although the efficacy results of this comparative study were unsurprising, the study’s authors also pointed out that disease duration prior to treatment was significantly related to worse outcomes, supporting that the earlier the treatment, the better chance for visual improvement (regardless of ranibizumab product used).

Tracking Two Bills to Remove the Clinical Efficacy Study Requirement for Biosimilar Development

Proposals in the House and Senate, both titled the Expedited Access to Biosimilars Act, may officially remove the FDA’s requirement for clinical efficacy studies for biosimilar candidates.

On July 15^th, a new bipartisan bill was introduced into the House of Representatives that would expand access to biosimilars by modernizing the FDA’s biosimilar approval process. This could be paired with a similar proposal just reaching Senate Committee discussion. Both of these proposals seek to reduce the cost of biosimilar development through squeezing out the need for comparative efficacy studies.

As reported earlier, the FDA in October 2025 announced a draft guidance that would achieve the same end, to remove the mandate for late-stage clinical efficacy trials for biosimilar manufacturers. However, a final guidance has not yet been released.

Introduced by Representatives Nick Langworthy (R-NY) and Kim Schrier, MD (D-WA), the Expedited Access to Biosimilars Act (HR 9661) could codify long-awaited regulatory changes to comparative trial expectations in the 351(k) biosimilar pathway.

According to a press release from Congressman Langworthy’s office, the act would eliminate unnecessary regulatory hurdles while preserving the FDA’s authority to require additional studies whenever scientifically warranted. This supports the October 2025 announcement of a draft guidance for removal of a mandate for phase 3 clinical efficacy studies for biosimilars. A key stipulation of the proposal would be a requirement for FDA to notify manufacturers early in the review process if additional late-stage comparative efficacy studies will be required. The aim would be to provide greater certainty around the clinical trial resources required for a successful biosimilar application process as well as avoiding unnecessary delays in the application process.

A number of associations have express support for the legislation including the Association for Accessible Medicines, the American Society of Health-System Pharmacists, and America’s Health Insurance Plans, among others.

The Senate’s 2025 Proposal

A Senate proposal by the same name (S.1414), introduced in April 2025 by Senator Rand Paul (R-KY), seeks largely the same goals. It has languished in the Committee on Health, Education, Labor, and Pensions, without additional cosponsors, until now. A committee meeting is scheduled for July 22 to finally consider this legislative proposal. It has one co-sponsor (Sen. Mike Lee, R-UT).

We’ll be monitoring whether the Expedited Access to Biosimilars Act can break through for an eventual debate and vote on either the House or Senate floor.

Another Big 3 PBM Settles With FTC on Rebates, Passthroughs, and Price Spreads

The Federal Trade Commission has reached a tentative settlement with the Big 3 PBM Caremark, which should increase the PBM’s transparency and has the potential for further reducing the use of rebate-based pharmaceutical pricing models.

In the latest salvo in the Federal Trade Commission’s (FTC’s) war on PBM practices, begun in 2024, it has reached a tentative settlement with CVS Health’s subsidiary Caremark, which should increase the pharmacy benefit manager’s (PBM’s) transparency and has the potential for further reducing the use of rebate-based pharmaceutical pricing models.

Announced on July 14, this is the second settlement with a Big 3 PBM formally announced by the FTC. A previous agreement with Express Scripts was reached in February, and the FTC stated in its press release that it is in active negotiations with OptumRx for a similar type of settlement.

TrumpRx Purchases to Count Towards Drug Deductibles

One of the interesting aspects of the settlement is the agreement by Caremark to incorporate purchases through TrumpRx under insureds’ pharmacy benefit—it will be counted toward drug deductible expenditures, as a standard offering to plan sponsors. These purchases would also be counted towards out-of-pocket maximums.

In addition, under the consent order, Caremark will be required to:

Cease discriminating against low wholesale acquisition cost (WAC) versions of a drug on its standard formularies
Provide a standard offering to plan sponsors that ensures that rebates will be passed through to members at the point of sale and that members’ out-of-pocket costs are no longer higher than the net cost to plan sponsors
Provide a standard offering to all plan sponsors that allows the plan sponsor to transition off rebate guarantees and spread pricing
Increase transparency for plan sponsors, assumedly through more frequent and comprehensive reporting
Separate the fees paid by drug manufacturers to PBMs or GPOs from list prices in its standard offering
Stop interfering with the ability of pharmacies in its networks to work with pharmacy hub service providers

These FTC agreements appear to be a valuable advantage for future biosimilars offered under the pharmacy benefit. Without a rebate-based reimbursement advantage, PBMs will have less incentive to retain reference products on their drug formulary, which opens the door to earlier access (and preference) of biosimilar agents.

Impact on Private-Label Arrangements for Biosimilars

It may also shed more light on private-label arrangements and pricing, through the transparency provision. Perhaps, the agreement will even inhibit the practice, through the provision prohibiting discrimination against low-WAC agents.

In these private-label arrangements, the biosimilars sold through the PBM distributor (in CVS’s case, Cordavis) are often substantially higher than other biosimilar brands, so that the PBM can profit from the price spread.

As a result, manufacturers of adalimumab and ustekinumab biosimilars, for example, have had to compete against their own private-label versions for market share. More importantly, it closed the access window on the fingers of manufacturers who did not reach private-label agreements, as these PBMs control more than 80% of the US prescription market, discouraging new biosimilar development.

There was no mention in the agreement about Caremark serving as a fiduciary to its clients, however, which would have further spotlighted the conflict of interest represented by these private-label arrangements.

According to the FTC, these terms are very similar to the terms reached in the settlement with Express Scripts earlier this year. The consent agreement is not finalized until a public comment of 30 days has elapsed.

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