Does the Direct-to-Employer Route for Biosimilars Make Sense?

Employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves. Going the direct-to-employer route, as Waltz Health and Fresenius Kabi are doing, would seem a natural option.

Waltz Health, a digital health company, has announced that it has agreed to team with Fresenius Kabi to help supply its three biosimilars in a direct-to-employer arrangement through its existing Waltz Connect platform.

First reported by Fierce Healthcare, the biosimilars that will be available direct-to-employer will be Fresenius Kabi’s Idacio (adalimumab), Tyenne (tocilizumab), and Otufli (ustekinumab). Waltz Health already has direct-to-employer arrangements with Eli Lilly and Novo Nordisk for their GLP-1 products.

By using Waltz Connect, corporate members can avoid traditional wholesaler and pharmacy benefit manager arrangements (and thus avoid rebate contracts). As the products are still delivered through specialty pharmacies, the typical provider and patient supports can still be provided.

The Direct-to-Employer Benefit for Biosimilars

This channel would appear to assure that patients directly benefit from discounts received by the corporate employer. In Fierce Healthcare, Fresenius Kabi’s President of Biopharma Sang-Jin Pak, MD, stated, “As we continue to expand our biosimilars portfolio, we remain focused on innovative partnerships that help employers and payers access high-quality treatment options.”

Employer benefit consultant F. Randy Vogenberg, PhD, told BR&R, “Making the costly drug purchase experience easier and engaging for the consumer as patient remains important. Leveraging biosimilar solutions could further the value to employers and their plan beneficiaries (patients) as other market forces change coverage affecting access to treatment options.” Dr. Vogenberg, Principal, FRV Health Strategy Advisory, Greenville, SC, said, “Addressing economic coverage gaps can be a win–win short-term solution for multiple stakeholders.”

Assuming that the employers signing onto Waltz Health have access to the same pricing for biosimilars as PBMs and others do, this seems a natural option. In surveys, employers have strongly indicated that they would like to move away from the big 3 PBMs for cost transparency and the ability to capture as much of the savings as possible themselves.

In Other Biosimilar News

Teva Pharmaceuticals received its second FDA approval for its denosumab biosimilar. After receiving its approval for Ponlimsi in March, referencing Prolia, to prevent osteoporosis, Degevma, referencing Xgeva, will be prescribed to prevent skeletal-related complications in patients with multiple myeloma or bone metastases. Teva plans to launch both products “in the coming months.” It joins a crowded field of 9 manufacturers with both denosumab indications.

Meitheal Pharmaceuticals announced September 28 that the FDA approved its high-concentration formulation of Yusimry, the company’s adalimumab biosimilar. The company will now be able to compete for prescriptions for this most-used adalimumab biosimilar formulation. “With this approval, we now have FDA approval for both low- and high-concentration formulations of Yusimry, marking an important step in expanding treatment options for patients with certain chronic autoimmune diseases,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. In July, the company had also received FDA approval for its insulin aspart biosimilar Garzulys, which is produced by Emerge Bioscience. Meitheal has marketing responsibility for this agent.

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.

Is the 505(b)2 Pathway Viable for Biosimilars?

With regulators focused on streamlining the 351(k) biosimilar development, it makes sense to wonder if the 505(b)2 pathway is valid for biosimilar approval.

Can discussions about streamlining biosimilar development reach into abbreviated approval pathways for small molecules? Based on a Stat News webinar I attended yesterday, they already have. What exactly are the differences between the 351(k) pathway for biosimilar candidates and the 505(b)2 pathway for small molecules?

Biosimilar-Type Products Already Approved Through the 505(b)2 Pathway

The 505(b)2 pathway was used for some products that are considered by most as biosimilars today. For example, Basaglar, the first copy of insulin glargine, was approved in 2015 through this pathway; it was before insulins transferred to the biosimilar pathway for approval in 2020. Admelog was the first insulin lispro copy, approved in 2017 through the 505(b)2 pathway as well. However, Granix, the first filgrastim molecule launched that was not Epogen or Procrit, utilized the 351(a) pathway, meant for innovator biologics; it predated the implementation of the 351(k) route to approval.

With streamlining of biosimilar development—a major focus of regulators today—it makes sense to wonder if the 505(b)2 pathway is a valid goal for biosimilar manufacturers.

Infographic comparing 505(b)(2) drug approval and 351(k) biosimilar pathways

The 505(b)2 application pathway was implemented through the Hatch–Waxman Amendments of 1984. It was not meant as an abbreviated pathway for generics, but rather a streamlined way to bring new forms of existing innovative medications to market. These are commonly referred to as “follow-on” products. The basis for its use is that the innovator product on which the follow-on molecule is based has a truckload of patient experience proving its safety and efficacy. The manufacturer would simply have to show that its product was very much like the innovator. Its application could range from new formulations, strengths, to other modifications that wouldn’t be expected to affect the structure or anticipated effectiveness.

According to Drug Patent Watch, development cost of a 505(b)2 product might be anywhere from $8 million to $20 million, and the timeline to reach the market (not counting patent litigation) could be as short as 3 years. The 505(b)2 pathway allows a manufacturer to utilize the innovator product’s preclinical and clinical data, requiring little more than comparability studies and bridging pharmacokinetic studies to reach the FDA application stage. The FDA may still require a phase 3 trial, which would change the costs dramatically, but it appears attractive in any case.

Of course, biosimilars require a bit more consideration, as they are far more complex than small molecules, for which the 505(b)2 pathway was intended. With the push to streamline biosimilar development, including waiving the phase 3 trial mandate, eliminate separate testing for interchangeability (and eliminate the designation itself), and drop the need for bridging studies, it is not difficult to visualize movement in this direction.

The Difference With Insulin as a Biosimilar

Yet, insulin is a relatively simple biologic molecule. It has decades of use and clinical experience supporting its safety and efficacy. When the 505(b)2 pathway was used to approve Basaglar and Admelog, few considered this a big risk (it may have helped that the first biosimilars were already approved and in clinical use).

Biosimilars are not follow-on products, unlike typical 505(b)2 agents. Rather, biosimilar manufacturers strive to make their candidates as close a copy as possible to the innovator (but realizing an exact match is impossible). Logically, it might seem that the biosimilar approval process should be at the same level of proof as the 505(b)2 pathway. No, that can never be the case—the structure of biosimilars will always be a little different than the innovator agent. And the structure will always change a bit over time (as will the innovator biologic).

It is better, instead, that the 351(k) pathway is modified to reflect the real-life experience of the biosimilars approved to date by the FDA and the EMA, and that does provide ample opportunity for lowering the bar, and costs, of development.

First Opdivo Biosimilar FDA Application Submitted by Amgen

Amgen became the first manufacturer to submit an application to the FDA for a nivolumab (Opdivo) biosimilar. It also was the first to be sued for patent infringement.

Last week, Amgen became the first manufacturer to disclose that they submitted an application to the FDA for a nivolumab (Opdivo) biosimilar. In doing so, Amgen also became the first manufacturer to be sued by the reference manufacturer Bristol-Myers Squibb for patent infringement.

The company disclosed the 351(k) application during a business presentation on September 10. Amgen’s product, ABP 206, is one of several publicly disclosed nivolumab biosimilar candidates. The company reported, “...for ABP 206, our biosimilar candidate to OPDIVO, our Biologics License Application with the FDA has been submitted and accepted for review. We expect an FDA action on that BLA by end of the year.”

Net 2025 US revenues for Bristol-Myers Squibb’s PD-L1 inhibitor were $5.9 billion. The intravenously administered drug was first approved in 2014 (and market exclusivity ends this year), and its main patent expiration is expected to expire in 2028. Bristol-Myers Squibb also introduced a subcutaneously administered version of Opdivo in 2024, which is approved only for specific cancers. Among other manufacturers who have publicly disclosed potential nivolumab biosimilars Sandoz, Xbrane, Henlius, and mAbxience, are in various stages of development.

Patent Infringement Suit Filed Against Amgen’s Opdivo Biosimilar

Within days of the announcement of Amgen’s FDA biosimilar application for ABP 206, Bristol-Myers Squibb initiated a lawsuit claiming infringement on at least 7 patents on their product. We estimate the earliest expected launch date for intravenously administered nivolumab biosimilars to be in 2029 based on a main patent expiration in late 2028. Based on past experience, the likelihood of a settlement between the two parties may be lower than for other prospective biosimilar manufacturers, as Amgen has been willing to go at-risk for launch in the past (specifically for its aflibercept biosimilar Pavblu, a product with a similar market size as nivolimumab).

Of further interest, Opdivo is often prescribed in combination with Yervoy (ipilimumab), which is also the focus of considerable biosimilar research (also involving Amgen). Amgen also disclosed during its business presentation that it intends to file its biosimilar application for ABP 234, its biosimilar candidate to compete with Keytruda, before the end of the year.

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.

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 Humira 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.

The Second Entyvio Biosimilar Is Under Review at FDA

On July 31, Fresenius Kabi and Polpharma Biologics announced that its 351(k) application was accepted by both the FDA and the EMA for PB016, a proposed vedolizumab biosimilar candidate to Entyvio

The second vedolizumab biosimilar candidate is now under review by the US FDA. On July 31, Fresenius Kabi announced that its 351(k) application was accepted by both the FDA and the EMA for PB016, a proposed vedolizumab biosimilar candidate to Entyvio lyophilized vial for intravenous administration.

PB016, in-licensed from Polpharma Biologics S.A., is a proposed biosimilar to IV vedolizumab, an integrin-receptor antagonist indicated for the treatment of adults with moderately to severely active ulcerative colitis and Crohn’s disease in adults.

“FDA and EMA acceptances for review of IV vedolizumab biosimilar marks important milestones in the development program and underscores our commitment to improving patient access to high-quality, affordable biologic medicines,” said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi. “With IV vedolizumab, we are advancing our autoimmune biosimilars portfolio and taking another step toward providing additional treatment options for patients living with chronic inflammatory diseases.”

The first biosimilar biologic licensing application was submitted in June by Alvotech and Teva.

In Other Biosimilar News

Amneal closed on its purchase of Kashiv Biosciences, a deal which “combines Kashiv’s biologics research, development and manufacturing capabilities with Amneal’s commercial scale, establishing biosimilars as a major long-term growth pillar within the Company’s Affordable Medicines business.”

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.