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.

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.

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.

Are Two Pegfilgrastims for Accord BioPharma Better Than One?

The FDA has approved the eighth pegfilgrastim biosimilar; now Accord BioPharma owns two of them: newly approved Ennumo and Udenyca

Accord BioPharma and its parent company Intas Pharmaceuticals announced that had it received approval on July 9th for a new pegfilgrastim biosimilar, which it has dubbed Ennumo (pegfilgrastim-pccg). The new biosimilar has been approved for all of the indications of the reference product Neulasta.

Why Two Pegfilgrastims?

What makes this approval interesting is that Accord and Intas already have a pegfilgrastim biosimilar, the product Udenyca, which is the number 2 pegfilgrastim product as of the end of 2025 (according to IQVIA). Udenyca was approved in 2018 by the FDA, and Accord acquired Udenyca once the original manufacturer, Coherus, decided to exit the biosimilar market. In the press release announcing the newest approval, Accord stated that it now has three separate granulocyte colony-stimulating factor, and “two distinct pegfilgrastim biosimilars” in its portfolio.

BR&R contacted Accord regarding how they intend to differentiate the two pegfilgrastim biosimilars. At present, Udenyca is available as both an injectable and in on-body injector forms. The new biosimilar Ennumo is available in the injectable form only. Otherwise, there is no difference in terms of dosing or indication. While Accord did not respond in time for publication, it may be possible that Accord intends to stop marketing Udenyca as an injectable, allowing Ennumo to take its place, or potentially selling only one brand or the other to certain segments of the US audience.

“Every FDA approval marks a step forward in our mission to expand patient access to high-quality, affordable biologic therapies,” said Chrys Kokino, President, Accord North America. “With Ennumo, we now offer healthcare providers the largest G-CSF portfolio in the world from a single biosimilar company.”

However, it is not yet clear how the additional pegfilgrastim biosimilar improves access. Overall, eight pegfilgrastim biosimilars are marketed today, in addition to the reference product.

Why State Employee Health Plans Should Push Hard for Biosimilar Use

A focus on biosimilars will save individual state employee health plans a conservative average of over $17 million, based on net costs.

A new survey from the Pacific Research Institute found that a greater focus on biosimilar utilization will save individual state employee health plans on average over $17 million each year, based on net costs.

In 2024, the year on which savings calculations were based, adalimumab biosimilars had begun to significantly cut into Humira’s market share, and savings were already being registered in a number of biologic categories, especially the oncology-related therapies.

State employee health plan savings with biosimilars

The study used data from CMS, IQVIA estimates, and a third party’s estimate of nonretail prescription drug expenditures. Based on these three sources, state private health insurance plans spent $20 billion on biologics in 2024. The author, Wayne Winegarden, PhD, Senior Fellow at Pacific Research Institute, confirmed to BR&R that these estimates are based on net prices, not gross costs. He estimates that roughly one-quarter of those expenditures were spent on biosimilars in categories of biologics with biosimilar competition, or a total of 7% of overall biologic expenditures.

State Employee Health Plans Save Big With Biosimilars

The research assumed two different scenarios: (1) biosimilars attain 52% of the biologic volume in categories with biosimilar competition (or 15% of overall biologic expenditures) and (2) 81% within those categories, or 24% of the overall biologic spend.

The author found that across the US, savings ranges from $871 million to $1.8 billion each year. From the analysis of individual states’ public employee health plans, biosimilars will save annually in the range in the from $0.9 million in Wyoming to $88.4 million in California (conservative scenario). In the more aggressive scenario, the biosimilars savings range was $1.8 million in Wyoming and $178.9 million in California.

Dr. Winegarden concludes, “Due to the savings potential, prioritizing biosimilars in state employee health plans will enhance the fiscal soundness of the state budget while ensuring state employees have access to efficacious treatments. This is an easy win-win outcome that will benefit both taxpayers and state employees.”

In Other Biosimilar News

According to a report in the Korea Biomedical Review, Celltrion was given the FDA interchangeability designation for its rituximab biosimilar product Truxima. This is perplexing for all of the reasons I’ve stated in the past: (1) the drug is not covered under the pharmacy benefit so it is not subject to the sole automatic substitution purpose of the designation and (2) the interchangeability designation does not in any way infer that the product is better than another biosimilar, yet the report noted that “Truxima remains the only rituximab biosimilar officially recognized by the FDA as interchangeable with the reference product, which it believes will provide a competitive advantage through greater physician confidence and market differentiation.” Any suggestion that an interchangeable is better than a conventional biosimilar is false. Rituximab biosimilars were first approved in 2018. How much additional confidence do prescribers need?

Samsung Bioepis Reboots Byooviz Marketing With Harrow at the Helm

Samsung BIoepis announced that it has relaunched Byooviz US marketing efforts with Harrow, the ophthalmology product commercialization partner it signed last July; Lupin receives FDA approval for its own ranibizumab biosimilar.

On July 1, Samsung Bioepis announced that the pause in marketing for its ranibizumab biosimilar Byooviz has come to a close, with the relaunch of the product with its new marketing partner Harrow.

Approved in September 2021 as the first ranibizumab biosimilar, Byooviz marketing efforts had dropped off since December 2025, when Biogen’s commercialization rights to the product were reverted back to Samsung Bioepis. Biogen had been responsible for commercialization of the product in the US.

“Today marks an exciting new chapter for Byooviz in the US. As the first FDA-approved biosimilar to Lucentis, Byooviz has already demonstrated its value in expanding access to critical retinal disease treatments. With Harrow now leading commercialization efforts, we are reigniting our commitment to ensuring patients and retina specialists across America to have access to this quality-proven, safe and effective biosimilar option,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, Samsung Bioepis. “We believe this relaunch will ultimately help more patients with critical ophthalmic diseases to receive the vision-saving treatments they need.”

A Difficult Road for Ranibizumab Biosimilars

Byooviz failed to gain traction for its intended market—patients with wet age-related macular degeneration, macular edema following retinal vein occlusion, or myopic choroidal neo vascularization. It reached its peak marketshare of about 8% in 2024, trailing its biosimilar competitor (Cimerli, then at 34%).

Overall, the biosimilar market for ranibizumab has a long climb back into the utilization picture: Byooviz has only 2% share, according to the latest Samsung Bioepis Biosimilar Market Report; Cimerli’s share dropped to zero, after a pause in marketing by Sandoz, caused by falling average sales prices. According to Q2 2026 report, ASP prices ranged from $320 to $398 for a 0.5-mg injection. However, the CMS July 2026 ASP file indicate a range of $255.45 for the reference product Lucentis to $1,204.85 for Byooviz for the 0.5-mg injection.

It is likely that the aflibercept market represents a greater opportunity for Samsung, Harrow, and the rest of the biosimilar industry relative to the ranibizumab category. Not only has ranibizumab had to battle for share against agents like aflibercept and newer technologies, but the use of off-label, compounded bevacizumab is also a constant threat.

Harrow will also market Samsung’s aflibercept biosimilar, Opuviz, when it is launched later this year.

Lupin Joins the Ranibizumab Fray

In related news, Lupin had announced that its own ranibizumab biosimilar has been approved in early June. This product, dubbed Ranluspec (ranibizumab-hkdz), will be available both as a vial and prefilled syringe.

In the company’s press release, Dr. Cyrus Karkaria, President – Biotechnology, Lupin, stated, “The US FDA approval of our biosimilar ranibizumab underscores our scientific expertise in biologics development and manufacturing, and reinforces our commitment to expanding access to advanced, affordable therapies for patients worldwide.”

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