Alvotech Submits First Entyvio Biosimilar Application to FDA

The first 351(k) application for a vedolizumab (Entyvio) biosimilar has been submitted by Alvotech. If approved, the biosimilar would be marketed by Teva. Alvotech also resubmitted biosimilar applications for golimumab and aflibercept.

On June 8, Alvotech announced that the FDA has accepted its biologic licensing application for AVT16, a biosimilar candidate for the reference drug Entyvio. This marks the first FDA 351(k) drug application for a vedolizumab biosimilar.

In its press release, Joseph McClellan, Chief Operating Officer of Alvotech, stated, “FDA acceptance of the BLA for AVT16 is another important step in advancing our mission to increase access to biologic medicines for patients worldwide. Our proposed interchangeable biosimilar to Entyvio builds on our experience in immunology and reflects the strength of our fully integrated development and manufacturing platform.”

Vedolizumab, an integrin-receptor antagonist, is currently approved to treat adults with moderate-to-severe ulcerative colitis and Crohn’s disease. The reference product is available in both intravenous infusion and subcutaneous injections.

Takeda’s US Entyvio net revenues were over $4 billion in 2024, but the biologic has been targeted for Medicare maximum fair price negotiation. The negotiated price will be implemented on January 1, 2028, unless biosimilar launch is imminent. The original drug patent is set to expire in 2026.

Intravenous Infusion vs. Subcutaneous Injection

AVT16 would be available only as an intravenous infusion. Alvotech’s biologic licensing application does not cover the subcutaneous injectable. A separate investigational product, AVT80, promises a biosimilar version of the prefilled syringe and autoinjector administration. Alvotech noted that the European Medicines Agency has received a marketing application for both AVT16 and AVT80. It is not clear whether Alvotech and its marketing partner Teva, intends to market these products under separate brand names if approved. The patent on the subcutaneous formulation may not expire until the 2030s, according to some sources, which may play into Alvotech’s decision to separate the FDA applications.

In Other Alvotech Biosimilar News

In November 2025, Alvotech received complete response letters from the FDA on two products—its biosimilar versions of golimumab and aflibercept. On June 4, 2026, the biosimilar manufacturer revealed that it had resubmitted its 351(k) applications to the FDA for both products (AVT05 for golimumab and AVT06 for aflibercept). Alvotech noted that it expects an FDA decision within 6 months. The complete response letters cited production facility issues, and not data or clinical quality questions. The latest FDA surveillance inspection of the Reykjavik production facility was completed by May 11, according to the company.

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 biosimilar approval database.

How Comfortable Are Neurologists With Biosimilar Prescribing?

With the October 2025 launch of Tyruko (natalizumab), neurologists have now been exposed to three different biosimilar categories, and one has been around since before the COVID-19 pandemic.

It’s logical to assume that when a specialty is exposed to biosimilar competition for the first time, acceptance and uptake of the biosimilar might be slow. The effort to educate specialists around the safety and efficacy of the biosimilar(s) may take time. In the past, manufacturers of the reference products countered competition with misleading marketing efforts to preserve their revenues. To cite just two examples, this occurred with gastroenterologists with the introduction of infliximab and with ophthalmologists with the launch of the first ranibizumab biosimilar. And then of course, there was the slow acceptance of adalimumab, based on different formulations.

Last October, the natalizumab biosimilar Tyruko was launched by Sandoz, primarily for the treatment of multiple sclerosis. Will neurologists’ biosimilar prescribing follow this stunted path? Only if you think natalizumab marks the first foray of biosimilars into the field of neurology medicine. In reality, this is not the case.

Eculizumab and Rituximab Biosimilars in the Neurology Toolbox

One reason that neurologists’ biosimilar prescribing will be quicker is that natalizumab is actually the third biosimilar used by these specialists. Eculizumab is usesd to treat patients with the neurological condition generalized myasthenia gravis. That drug has been available as a biosimilar since March 2025.

Although many neurologists have moved from the eculizumab reference drug Soliris to the follow-on brand Ultomiris, the appearance of biosimilars has likely exposed them to more prior authorization and/or step therapy, encouraging the use of lower-cost eculizumab biosimilars. Additionally, their experience with buy-and-bill eculizumab biosimilars gave them a brief preview of buy-and-bill reimbursement for the natalizumab biosimilar.

Another factor impacting neurologists’ biosimilar prescribing is not so obvious: A significant portion have been prescribing rituximab and its biosimilars off label to treat some neurologic disorders, including myasthenia gravis, multiple sclerosis, and neuromyelitis optica spectrum disorder. And rituximab biosimilars were approved since 2018.

Neurologists May Be More Comfortable With Biosimilars Than You Think

In working on a survey of 40 practicing neurologists for a biosimilar manufacturer and marketer, it became apparent that the respondents were far more familiar with biosimilars than we may have assumed.

In the case of the present survey, which was conducted just before the launch of Tyruko, 41% of the neurology sample had indicated they had experience with rituximab biosimilar prescribing s within the previous 12 months. This may have contributed to the view by 40% of the sample that the use of either eculizumab or natalizumab biosimilars would not have any effect on their practice. An additional 22% believed the biosimilars might actually result in greater profits. This should certainly make it easier for makers of biosimilar forms of market-leading Ocrevus, when they are launched in 2028.

Watch for further insights from this survey project in the next month, once the full results are published.

First US Approval for a Golimumab Biosimilar: Immgolis and Immgolis Intri to Launch by End of 2026

Bio-Thera Solutions and Accord Biopharma received an FDA approval on May 15, 2026 for the biosimilar forms of Simponi and Simponi Aria. Dubbed Immgolis and Immgolis Intri, this first-in-class golimumab biosimilar should be available before the end of 2026.

On May 15, the FDA approved the first golimumab biosimilars, Immgolis and Immgolis Intri (golimumab-sldi) for the reference products Simponi and Simponi Aria, respectively. Commercialized in the US by Accord Biopharma, Immgolis was developed and manufactured by Bio-Thera Solutions. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.

Immgolis is approved for the treatment of severely active rheumatoid arthritis (RA), in combination with methotrexate, and for the treatment of moderately to severely active ulcerative colitis. The Immgolis Intri formulation is approved only for adults with moderately to severely active RA in combination with methotrexate. This does not represent the full set of indications of the reference product, as Simponi is also indicated for the treatment of active psoriatic arthritis alone, or in combination with methotrexate and active ankylosing spondylitis.

“As the first golimumab biosimilars approved in the US, Immgolis and Immgolis Intri represent a meaningful new option for people in the US who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” stated Chrys Kokino, President of Accord North America, in the company’s press release. He added, “This approval answers a clear demand in the US market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030.” Launch is expected by Accord BioPharma in the fourth quarter of 2026.

The outlook for biosimilar competition in this category is somewhat limited, in that there has been only one other publicly disclosed golimumab biosimilar. That product, AVT05, is produced by Alvotech and will be commercialized by Teva postapproval. Its initial 351(k) application was accepted by the FDA in January 2025, but the drug makers were issued a complete response letter for manufacturing issues in November 2025.

Golimumab is a TNF inhibitor, and Immgolis will compete against not only the other biosimilar TNF competitors (e.g., adalimumab and infliximab) and their low net prices, but with the approved interleukin biosimilars (e.g., ustekinumab) as well for the same autoimmune indications.

More on the Dynamics of the Biosimilar Marketplace

In this post, we summarize market share and average sales price (ASP) trends for several notable biologic categories with biosimilar competition, courtesy of the Q2 2026 Samsung Bioepis Market Trend Report.

Over the years, we’ve observed the effect of biosimilar competition on biologic pricing, generally in the form of ASP and wholesale average cost (WAC) declines. Even when biosimilar competition was less than robust, prices declined steadily for some drug categories, shockingly fast for others. But the savings keep accumulating.

The Pegfilgrastim ASP Roller Coaster

The pegfilgrastim category has been fascinating since its first biosimilar was launched in late 2018. The ASP declines, plateaus, rises, and falls once again have been chronicled in this column in the past. Perhaps the main take away of the biosimilar ASP chart featured in the latest Samsung Bioepis Market Trend Report is that the graphic jumble of ASP movements have finally coalesced into a narrower range, between $1,813 at the top end for Stimufend and $839 at the bottom end for Fulphila; the latter is also the market leader with 41% share (as of Q4 2025).

The wild ASP rollercoaster of chart lines has taken three years and some stops and starts by manufacturers like Sandoz before reaching this station. Market share in this category is dominated by biosimilars, with Neulasta accounting for only 13% of volume; however, Onpro is not included in IQVIA’s data, so it is far from the whole story.

Biosimilars Leading the Autoimmune Field

On the autoimmune side, biosimilars have just reached a majority share of the infliximab market, with 51%, but the reference product (branded and unbranded Remicade) still has the greatest volume (49% vs. 30% for Inflectra). Here also, the ASPs of the various products have settled into a narrow range ($237-$293).

Based on the IQVIA data, the latest Samsung Bioepis report concedes that Humira’s prescription volume has been eclipsed by the mass of adalimumab biosimilars currently on the market. The authors peg Humira’s market share at 40%, and this is probably generous, because IQVIA does not track Cordavis private-label volume. The individual biosimilar shares are closely grouped, with Hyrimoz at 13% down to Amjevita at 4% (Nuvaila’s private-label version adds another 5%), and at least four others combining for 7% in total.

The tocilizumab market, which is about 2 years old, is showing slow gains for its three biosimilars, which comprise 18% of total prescription volume. It is led by Tyenne (16%), which also has the lowest published ASP, at $1,607, a 23% discount to the reference product’s ASP.

For ustekinumab, Stelara’s market share had already been knocked down to approximately 70%, as of Q4 2025, a far faster trajectory than that seen with adalimumab. Yesintek, at 11%, holds a narrow lead over Wezlana (7%). As we have seen at their introductions, the WAC pricing discounts have been extremely steep, led by Starjemza (–98%, or $500 total). But this is the first quarter for published biosimilar ASPs in the category, which come into play because ustekinumab requires an infusible loading dose for some indications, which is given by a health care provider under Medicare Part B. The loading dose ASPs have a wide initial range, from $286 for Steqeyma, to $1,643 for Pyzchiva. The average ASP of the biosimilars is $753, compared with $1,426 for Stelara.

A Failed Biosimilar Ophthalmology Category, or not Really?

Overall, the report details a generally, very positive biosimilar story. The one drug category where this is not the case, is ranibizumab. With the pause in commercialization of Cimerli, the low uptake of Byooviz, and the dominance of aflibercept and bevacizumab in the injectable retinal care product, marketshare of the reference product Lucentis has returned to 98%. Despite the lack of biosimilar success, the ASPs for the category hover between $320 and $398, a 72% drop cited by the report’s authors. Unfortunately, IQVIA data does not yet include the effect of the launch of the first biosimilar on the aflibercept market. We’re betting on another big success story here.

FDA vs. EMA Biosimilar Approvals, an Update

In 2026, the number of EMA-approved and FDA-approved biosimilar drug categories are now even. However, the number of marketed US biosimilars is less than half of that in the EU.

When looking at the approvals by the European Medicines Agency (EMA) of biosimilars since the initial approval back in 2006 for somatropin biosimilar, it becomes clear that the US FDA has caught up in terms of the drug categories for which biosimilars have been approved. However, the total number of approved biosimilars in the UK still far outpaces those in the US, on the order of 168 to 81 (I don’t count each denosumab molecule twice, against the reference products Prolia and Xgeva). That’s in 26 drug categories (compared with 20 in the US).

150 Marketed Biosimilars in the EU

According to the Generics and Biosimilars Initiative (GABI), presently 150 biosimilars are actually available for marketing. Digging into the number of biosimilars available in any one category, such as denosumab, the EMA has approved 14 manufacturers’ products (under 28 different brands), compared with 11 in the US, guaranteeing intense competition.

Several drug categories that the EMA list as biosimilars were not originally considered biologics by the FDA or were converted to the biologic category in 2020; however, this was after pharmaceutical company interest waned in the US for these drugs. This was the case for follitropin, enoxaparin, somatropin, and teriparatide. Basaglar is approved as an insulin glargine biosimilar by the EMA but as an insulin glargine follow-on product (or 505[b]2) by the FDA. And the EMA split epogen biosimilars into two categories, epogen alpha and epogen zeta, for some reason, whereas we only have the former.

There is only one drug category for which the FDA has approved a biosimilar that the EMA hasn’t (at least for now): That is pertuzumab. Partners Henlius and Organon have the sole FDA-approved biosimilar in the category.

Other fascinating areas of difference among the regulatory regions is that there are six ranibizumab biosimilars in the EU as opposed to only two active in the US; there are 14 ustekinumab biosimilars approved by the EMA as opposed to 8 in the US (not including private labels).

Of course, the number of approvals does not foretell the number of launches, especially in the US, where we are still awaiting the first etanercept biosimilar launch, 10 years after Europe’s introduction.

The real question is, who will delve quickly into the biosimilar void?

In Other Biosimilar News

Teva announced on March 30 that it received FDA approval for its Prolia biosimilar Ponlimsi (denosumab-adet). The drug is approved for all of the bone health indications of the reference product Prolia. Originally designated TVB-009, it is also under consideration by the FDA for Xgeva’s oncology bone health indications. It is the 10th denosumab biosimilar approval to date.

In other Teva news, the company also announced that the FDA has accepted its 351(k) application for TEV-45779, its omalizumab biosimilar. An FDA decision is expected in Q1 2027 on this third Xolair biosimilar product.

The FDA’s New Draft Guidance Contributes to Streamlined Biosimilar Development

The FDA positions non-US-licensed reference products as adequate for clinical pharmacokinetic investigations and to reduce data redundancy

The FDA on March 10th released new draft guidance for the biosimilar industry that begins to tie together some of the concepts in streamlining biosimilar development that has been discussed for some time now. The new guidance goes beyond the phase 3 comparative efficacy study mandate removal in October 2025 and touches upon the need to test a biosimilar against a US-licensed reference product as well as the need for redundant pharmacokinetic testing requirements.

FDA releases new draft guidance streamlining biosimilar development

In the fourth revision of its Q&As on biosimilar development , the FDA specifies that, in certain circumstances, a sponsor can use data from a non-US-licensed reference product for comparison if it can scientifically justify why “such comparative data are relevant to the assessment of biosimilarity to the US-licensed reference product.” This assumes that the non-US product has been approved, licensed, and under the regulatory authority of an organization with similar standards to those of the FDA.

This new guidance could have two significant effects: (1) It would reduce the need for replicative pharmacokinetic investigation (to show the equivalence of the ex-US reference product to the US-licensed reference product and (2) it would remove the need for biosimilar companies to run additional clinical pharmacokinetic studies on a new biosimilar candidate. With reference products costing far less outside the US, not requiring a US-licensed comparator product would save biosimilar manufacturer significant R&D dollars in the purchase of the many doses required for analytic testing.

The FDA also specifies that “Differences in strength or dosage form between the US-licensed reference product and non-US-licensed comparator product do not necessarily preclude use of the non-US-licensed comparator product in a clinical study intended to support a demonstration of biosimilarity.”

This draft guidance does not exactly lead the way to a global comparator product, but it is progress toward that end. Also, one other note, we are still awaiting the final guidance from the FDA, officially removing the clinical efficacy study requirement.

A Filgrastim Biosimilar Approval, and a Bevacizumab Rejection

Accord BioPharma received approval for Filkri, a filgrastim biosimilar, and Outlook Therapeutics journey to approval for its ONS-5010 continues after an FDA rejection.

A Filkri Approval for Accord BioPharma

In mid-February, Accord BioPharma announced that it had received FDA approval for Filkri (filgrastim-laha), making it the fifth filgrastim biosimilar to obtain approval (not counting Granix, a 505[b]2 product that launched before the biosimilar approval pathway was established). Accord now has both filgrastim and pegfilgrastim biosimilars in its portfolio. It had acquired the Udenyca franchise from Coherus in 2024.

Biosimilar uptake in the filgrastim category (reference product, Neupogen) is approximately 75%, according to the latest Samsung Bioepis Biosimilar Trend Report. The discount in average sales price (ASP) since the introduction of filgrastim biosimilars in 2015 has been 74%.

Outlook Therapeutics Rejected Again by FDA

The battle to bring a manufactured bevacizumab for ophthalmic use is not yet over in the US. Although approved by the European Medicines Agency, Outlook Therapeutics ONS-5010 has been in a long-term journey to US commercialization.

“The [latest complete response letter] identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence,” according to a press release from February 17. “Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the [biologic licensing application], including data from an adequate and well-controlled study and confirmatory evidence of effectiveness.” Outlook indicated that discussions with the FDA since September 2025 seemed to indicate alignment with the agency on the important issues. The company has sought additional meetings with the FDA to understand a path forward.

Indeed, we have been following Outlook Therapeutic’s journey for several years, along with its complete response letters in 2023 and 2024. With the low cost of compounded bevacizumab and its high utilization in retinal disease, it was hoped a manufactured version of this product for intravitreal injection would help address safety and purity concerns with compounding and at well below the cost of ranibizumab and aflibercept. However, with heavy biosimilar competition by later this year for the latter, it may be more difficult to leverage a much lower price point for ONS-5010 if launched in 2027.

This article was written by our Director of Content, Stanton Mehr. Stan is 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.

Update on Amgen’s Pavblu Launch Success

Amgen’s Pavblu has been the most successful US biosimilar launch by any manufacturer to date, with more than $600 million in net sales in 2025.

The February 3^rd earnings report released by Amgen underscore the major success of its Pavblu launch, the first biosimilar competitor to Eylea. For the full year 2025, US net sales were $691 million, the company’s most successful biosimilar launch to date. In the fourth quarter of 2025 alone, Amgen registered $254 million in sales, putting it on a potential path to $1 billion in annual sales, though several other biosimilar competitors will enter the market in 2026.

Amgem's earnings report underscores the major success of its Pavblu launch.

The maker of the reference product, Regeneron, confirmed 42% lower sales of Eylea, to $2.38 billion in the US, but also 36% greater sales of Eylea HD, to $1.64 billion.

On a net sales basis—not a prescription volume basis—it would appear that Amgen has a 30% share of the aflibercept non-HD market and a 9% share of the entire aflibercept franchise market. These data support the greater story of this aflibercept biosimilar launch success and the race by Regeneron to move prescriptions to the Eylea HD formulation, before payers prefer the less-expensive biosimilar competition.

The Pavblu launch success was driven by Amgen’s decision to begin marketing the first aflibercept biosimilar at risk, and it will remain the only aflibercept biosimilar on the market until the second half of 2026.

In Other Biosimilar News

Here’s more news on an aflibercept biosimilar launch—this one by Samsung Bioepis. According to a press release, the company and the reference manufacturer Regeneron announced an agreement February 12, allowing the US launch of Samsung Bioepis’ Opuviz in January 2027. At that time, Samsung will have both ranibizumab and aflibercept biosimilars in its ophthalmologic portfolio.

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 14 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.

An Injection of Support for the Biosimilar Red Tape Elimination Act

Thirty-seven organizations representing manufacturers, health plans and insurers, pharmacy benefit managers, corporate employers, consumers, and patients have banded together to support and hopefully reinvigorate action to pass the bicameral Biosimilar Red Tape Elimination Act.

The Biosimilar Red Tape Elimination Act has been long-awaited, but it is not making much progress through Congress. As of January 22, the House version (HR 5526) has four co-sponsors since its introduction in September 2025. The related legislation in the Senate (S 1954) was introduced in early June last year, sat in Committee since that time, and similarly has gained only four co-sponsors.

In October 2025, FDA Commissioner Marty Makary, MD, stated that a draft guidance was being written to address the same objective—redefine interchangeability for biosimilars so that any approved biosimilar is deemed interchangeable. As of January 22, the bills are stuck in committee, and the FDA has not issued the anticipated draft guidance.

No Clinically Meaningful Difference Between Biosimilar and Interchangeable Biosimilars

The Association for Accessible Medicines announced the joint letter, which was sent to the chairmen and ranking members of the House and Senate committees, where the bills currently reside, asking them to “advance this crucial legislation.”

“There is no clinically meaningful difference between biosimilar and interchangeable biosimilar medicines,” said John Murphy III, President and CEO of AAM. “Interchangeability is a designation created by legislative language instead of science, doesn’t exist in any other country. We are thankful to the bill sponsors in the House and the Senate as well as the many groups who have joined us.”

“Unfortunately, the statutory distinction between biosimilars and interchangeable biosimilars continues to generate confusion and misinformation about the safety of biosimilar medicines,” states the letter. “The [FDA] has consistently affirmed that there is no scientific difference between biosimilars and interchangeable biologics.”

This article was written by our Director of Content, Stanton Mehr. Stan is has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 12 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.

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