Biosimilar Company Acquisitions: Amneal and Sun in Separate Deals Signal More Generic Drug Maker Participation

Amneal has gone from purchasing a subsidiary to acquiring 100% of Kashiv Biosciences, LLC; and India-based generic drug maker Sun Pharmaceuticals is acquiring Organon.

Amneal Pharmaceuticals to Buy Kashiv Biosciences for $1.1 Billion

Over the past couple of years, Kashiv Biosciences, LLC has served as an R&D engine for Amneal Pharmaceuticals’ biosimilar commercialization business. Whereas Amneal had previously purchased a subsidiary of Kashiv (Kashiv Specialty Pharmaceuticals) in 2021, it announced on April 22 that it intends to purchase 100% of the parent company.

According to Chirag Patel, Co-Founder and Co-Chief Executive Officer of Amneal, “With Kashiv, Amneal becomes a fully integrated global biosimilars leader at the forefront of the next wave of U.S. affordable medicines. This acquisition is a natural next step in our strategy to build a leading, diversified biopharmaceutical company, and we are confident it will drive accelerated growth and long-term value creation.”

As part of the deal, Amneal will obtain two US production plants and two India-based production facilities.

The $1.1 billion transaction includes $375 million in cash at closing, along with $375 million of equity. Kashiv will also receive up to $350 million in potential payments upon attaining specific regulatory milestones, in addition to royalties on its products. Amneal expects that the acquisition will close before the end of 2026.

Organon to Be Sold to Sun Pharma for $11.75 Billion

Sun Pharmaceutical Industries officially entered the biosimilar market, by announcing its $11.75 billion acquisition of Organon. Organon was spun off from Merck in 2021, and focused on both biosimilar commercialization and the sales of other branded pharmaceuticals, including women’s health products. Mumbai-based Sun Pharma is India’s largest generic pharmaceutical manufacturer.

Under the transaction, Organon will be merged with the parent company’s Sun Pharma subsidiary. The transaction should close in early 2027.

In statements made in Sun’s press release, it is unclear what value Sun places on the biosimilar part of Organon’s business. However, the move does position Sun as a global biosimilar player, with a presence in 150 countries. Will Sun leverage Organon’s position as a biosimilar commercialization partner and contract with other manufacturers and/or will Sun move into the biosimilar R&D game as well?

Biosimilars as a Natural Evolution for Generic Manufacturers

The moves by Amneal and Sun may presage moves by other generic drug makers to expand their horizons. As we’ve seen and heard at the recent meetings and at IQVIA presentations, the generic drug industry is at a crossroads—profits are being squeezed out and generic drug launches are slowing to a trickle. Scott Biggs of IQVIA stated at the Association of Accessible Medicines Access! Meeting earlier this year, “In 2018, it took seven branded drugs to equal the total revenues of the generic business; today, it only takes two.”

Generic company sustainability is certainly an issue, and the biosimilar field seems a natural expansion for these companies. This is especially true as efforts to streamline the biosimilar development process significantly lowers the costs of entry.

Although a few biosimilar manufacturers have found handsome profits in the biosimilar industry, many find only limited revenues for several products, including those with small market shares of adalimumab, pegfilgrastim, ranibizumab, infliximab, and others. However, $50 million in annual revenues for an individual biosimilar may be acceptable to a generics company with 50 other products in their portfolio. Ask generic manufacturers like Biocon, Amneal, and Dr. Reddy’s.

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.

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.

Market Share vs. ASP: Do Oncology Biosimilar Trends Make Sense?

The latest Samsung Bioepis Biosimilar Market Report (Q2 2026) was released yesterday, and it reveals a host of intriguing movements in both price and market share of biosimilar agents. In this post, we’ll look at the oncology category.

The movements of one of the most established drug categories—trastuzumab—caught my eye in the newest release of the Samsung Bioepis Biosimilar Market Report. It perhaps highlights how the US drug pricing system seems to encourage strange market trends.

Biosimilars have been available in the category since 2020. One might expect the story of the trastuzumab biosimilar market to be stable and essentially straightforward. This is true when viewing market share data. Three products have shares of 24% and above: Kanjinti (31%), Trazimera (25%), and Ogivri (24%), and these shares have not moved much over the course of a couple of years. However, the average sales price (ASP) listings for these products are all over the map, and they are moving in wildly different directions.

The Case of Trazimera

Pfizer’s Trazimera is of particular interest. Based on the latest IQVIA data, the biosimilar’s ASP bounced up from $112 to $205 in the last quarter, after dropping a whopping 88% (from $938 to $112) in Q4 2025. Trazimera’s ASP is currently 80% below its nearest price competitor (Ontruzant).

On the opposite side of the scale, Kanjinti still has the highest ASP of any trastuzumab biosimilar, at more than 10 times the price of Trazimera, yet it is the market share leader (Table). For comparison, the reference product Herceptin has an ASP of $2,909, about 19% higher than Kanjinti’s but has only 3% market share, which is the only thing here that makes sense.

Trastuzumab Biosimilar/Market Share	ASP Pricing	Percent Lower Than Current ASP of Reference Product
Trazimera (25%)	$205	93%
Ontruzant (2%)	$1,109	65%
Ogivri (24%)	$1,270	56%
Hercessi (3%)	$1,358	53%
Herzuma (2%)	$2,120	27%
Kanjinti (31%)	$2,135	27%
Data from Samsung Bioepis Biosimilar Market Report Q2 2026.

Although this may be another case of a buy-and-bill product being preferred because of a higher price and thus higher reimbursement, it does not explain why Trazimera holds a full quarter of the total trastuzumab market. It could be that this is the product preferred by systems and practices being paid through value-based reimbursement, like shared savings. However, the other market leader, Ogivri, has a midrange ASP and a similar marketshare.

In the bevacizumab market, this appears not to be the case. Mvasi, with a 51% market share, has the lowest ASP. In the case of rituximab, Ruxience owns 39% of the market and is by far the lowest-priced agent. However, the second lowest-priced agent (Riabni) has only a 7% share, and Truxima, with a 31% share, costs three times as much as Ruxience.

In the next couple of posts, we’ll delve into some additional interesting biosimilar market share market trends, as described by the latest data.

Pharmacy’s View on MFN, MFP, and Drinking From the Firehouse

At the twice-yearly meeting of the Academy of Managed Care Pharmacy (AMCP), the job of the Government and Regulatory Affairs group is to brief members and attendees on the latest federal and state developments that affect health plan, pharmacy benefit management, and pharmacy in general. Much of this activity intersects with the biosimilar industry, as the managed care pharmacy and biosimilars sectors are inextricably linked.

At last week’s 2026 annual AMCP meeting, it was a particularly weighty task for the Academy’s Adam Colborn, JD, and Geni Tunstall, JD, to track and make sense of the torrent of federal initiatives released since AMCP’s Fall meeting in 2025. Indeed, Mr. Colborn, Vice President, Government Affairs, characterized his job over the past six months as drinking from a fire hose.

In just the past four months, we’ve seen action from the White House on most favored nations (MFN) pricing in the form of GENEROUS, GUARD, and GLOBE demonstration programs and TrumpRx; and the Federal Trade Commission’s settlement with Express Scripts. To top it off, Congress passed the Consolidated Appropriations Act of 2026 (CAA), with its emphasis on PBM reform.

Reforms and Settlements

Waiting in the wings is 340B reform along with other FTC agreements with the big 3 PBMs, a court fight over the new Section 232 pharmaceutical tariffs, a proposed rule for PBM transparency by the Department of Labor, and the brand-new charter by HHS of the Advisory Committee on Immunization Practices.

Additionally, Mr. Colborn pointed out, brand new legislation has been introduced that goes after vertical integration in healthcare. The Break-up Big Medicine Act (Senate bill 3822) does not have a parallel bill in the House, so it has a lesser chance of enactment, but he believes if passed, “it would be hugely disruptive to the health care system.”

Because PBMs have already begun to evolve away from a reliance on the rebate model to sustain their bottom lines, the provisions of the CAA “may be less impactful than it might have been if enacted five or six years ago,” said Mr. Colborn.

Codifying Opaque MFN Agreements

Geni Tunstall, Associate Vice President of Regulatory Affairs, said that “so far, the Great Health Care Plan seems to be a little more than loose concepts rather than a coherent strategic initiative.” Indeed, one of the more ironic musings heard at the meeting was that the Trump plan was a little more than plans to install a defibrillator in the White House’s new ballroom. However, Ms. Tunstall remarked that other than a desire for Congress to codify the MFN arrangements to ensure the durability of pricing negotiations between the administration and the pharma companies, there seems to be little behind a greater health plan reform effort.

Under MFN, which is now subject to voluntary agreements with 16 manufacturers, there is little known about the negotiations themselves, said Ms. Tunstall, and perhaps the bigger question, “How will patients benefit from MFN models?”

Furthermore, there is a question as to whether the shorter-term contracting processes used in the MFN-based GLOBE and GUARD models will support the effectiveness of these 5-year demonstration projects.

What Happens Next for MFN?

At a separate session on MFP and MFN pricing, pharmacists speculated on the unintended consequences of the move towards MFN pricing. Lisa Kennedy, PhD, Chief Economist at Innopiphany, reminded the attendees that the European mechanism for determining pharmaceutical pricing for pharmaceuticals is unlike that for the US: not only do many EU countries rely on contract tenders or bidding processes, but several countries actually seek to rationalize drug pricing through a calculation of drug value (as the UK does with the National Institute for Clinical Effectiveness). This implies that simply pegging US prices to what Europeans pay would not be a long-term solution and would result in accelerated drug withdrawals from the market, delayed launches, or even approvals in the US but no intention to launch in this country.

International prices will inevitably rise as our prices fall, squeezing the manufacturer in the middle. We can also expect reduced price transparency, as companies tried to come to agreement with individual governments. And how tariffs play into existing MFN strategies or negotiations is anyone’s guess.

Deb Curry, PharmD, Chief Clinical Officer of Health Delegates, emphasized the role of transparency. Clinicians want to see the patient’s whole picture, but the impetus to go outside of the pharmacy benefit through direct to consumer purchasing challenges the industry’s ability to pull this information together. There are doubts, Sarah Rivera, PharmD, noted, that patients will spend hundreds of dollars on TrumpRx or any other DTC site for chronic medications, thus making the point moot.

Additional unintended consequences of both the MFN and MFP initiatives include an estimated 48% potential reduction in biopharma patents, with job losses in the pharma industry of 472,000 over a decade. With a narrow pricing corridor, drug companies may elect to delay launches, withdraw from certain markets with lower prices, and likely increase drug prices upon launch.

It is difficult to know whether the firehose spigot has been turned off for now or there are new poorly considered initiatives on the table. We do know that all of these will not work well in a well-timed sequence of events or concurrently to improve the health system. There’s chaos not coordination, and that seems to be the order of the day in this administration.

100% Tariffs Slapped on Pharmaceutical Companies, With Many Exceptions: Circumventing the Supreme Court?

On April 2, the Trump administration announced a new round of tariffs, this time affecting the branded pharmaceutical industry. The threat of 100% tariffs on patented drug products and their active ingredients has the industry seeking to understand the explanations and its several exemptions.

Yesterday, the White House issued a new set of tariffs on the pharmaceutical industry, charging the full list price of an imported brand-name or patented drug for certain companies and locations. In the face of the Supreme Court’s rejection of the president’s general global tariff authority, it seems unlikely that these tariffs will not be challenged.

Where Is the Evidence That Pharma Tariffs Will Shore-up Supply Chains and National Security?

In August 2025, President Trump signed an executive order seeking to bolster the pharmaceutical supply chain. It is doubtful that these new “Section 232” tariffs will have a positive effect on the drug supply chain, as any onshoring of new pharma production is a years-long process. Furthermore, these tariffs will be enforced for only specific companies, with several exemptions.

Enforcing tariffs on patented medicines and their agreements does virtually nothing to support national security, which is the goal of Section 232 of the Trade Expansion Act, under which the president still has specific tariff authority. In the White House’s fact sheet, the administration claims that “An investigation [by the Commerce Department] found that patented pharmaceuticals and associated pharmaceutical ingredients are being imported into the United States in such quantities and under such circumstances as to impair our national security.” This is an extremely vague and ambiguous claim, without any evidence (persuasive or otherwise) of a direct national security threat.

The Real Pharma National Security Threat

Simply because a pharmaceutical company sells a drug in the US but does not produce it here does not present a threat to national security. If that product was solely produced by an adversarial country, and there were no therapeutic alternative for that product, then you might be able to make a tenuous case, at best. Ironically, that situation might only truly exist in the face of a new pandemic; in that case, do you really want to double the cost of the potential life-saving treatment? The administration has strongly indicated its position against US mRNA vaccine research by severely cutting funding. I’m guessing that the Trump administration would have to give that country an exemption faster than he could post to Truth Social.

It’s All About the MFN Agreements

There are plenty of exemptions to these new tariffs, the dominant one is that for companies that had reached most favored nation (MFN) agreements with the administration. According to the White House, these companies are exempt from the new tariffs (for 3 yr). This strongly supports that the motive is not national security but about compelling pharmaceutical companies to come to heel. The exemptions undercut any claim that a Section 232 investigation applies to the pharmaceutical industry. It is again trying to leverage the government’s position to force pharmaceutical companies without MFN agreements to join the large group that have signed on already. The administration’s own deadlines don’t try to hide this fact: The tariffs will come into effect within 120 days for large companies that have not already forged agreements with the administration and 180 days for smaller companies to fall in line.

In addition to pharma companies that have agreements in place there are several other exemptions as well. For example, if a pharmaceutical product is from the EU, Japan, Korea, and Switzerland, a 15% tariff will apply. For pharmaceutical companies in the UK, which like the others also have existing pharmaceutical tariff deals, a lower tariff will be assigned. Companies that have entered onshoring agreements with the Department of Commerce for facilities to produce their pharmaceuticals in the US will be subject to a 20% tariff, which will increase over time. Orphan drugs are exempt, as are biosimilars and generics (however, the administration says that position will be reassessed one year from now).

Will this new Section 232 tariff make the rounds in federal court? It certainly should. It is about coercion, not about supply chains or national security.

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.

Samsung Bioepis, Sandoz Forge Deeper Biosimilar Ties

Five early-stage biosimilar candidates from Samsung Bioepis will be marketed in various parts of the world by Sandoz, including SB36, for which Sandoz will hold marketing rights in the US.

Samsung Bioepis, which had earlier this year announced a substantial biosimilar infusion to its pipeline, entered into a marketing agreement on March 18th with Sandoz for at least one of its early-stage biosimilar candidates in the US.

The company specifically announced that its biosimilar for vedolizumab (SB36) will be marketed by Sandoz in the US and in most world markets, excluding Southeast Asia.

Vedolizumab Biosimilars and More in the US?

Beyond this Entyvio biosimilar candidate, Samsung did not suggest that Sandoz would be its US marketing partner for its other biosimilar targets, which include Keytruda, Taltz, Ocrevus, among others. However, Samsung Bioepis did state in its press release that the new agreement covers up to five biosimilar candidates (which may cover various global markets).

“We are very pleased to expand our successful partnership with Sandoz and to secure commercialization agreement for multiple biosimilar assets that are in early-stage development. The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis.

The Sandoz Biosimilar Pipeline Grows as Well

On the other hand, Sandoz has its own Keytruda biosimilar candidate (GME751), which suspended its late-stage clinical trial before the FDA’s announcement of its planned move away from requiring phase 3 trials. Sandoz also has its own Opdivo and Yervoy biosimilar candidates.

This arrangement fortifies Sandoz’s existing partnership with Samsung Bioepis, which already includes marketing agreements for the latter’s ustekinumab (Pyzchiva) and eculizumab (Epysqli) biosimilars. It adds to the roster of biosimilars in Sandoz’s pipeline as well.

Richard Saynor, Chief Executive Officer, Sandoz, stated in a press release, ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalizing on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”

As Oncology Biosimilar Acquisition Prices Fall for Hospitals, Biosimilar Adoption Rises

A recent study published in JAMA found that as the acquisition prices of bevacizumab, rituximab, and trastuzumab fell from 2020 to 2024, hospitals’ profits on each biosimilar purchase increased, and the uptake of these oncology biosimilars rose quickly. This could be an important lesson for the upcoming Keytruda and Opdivo biosimilar launches.

Researchers from the University of California, Berkeley and Brown University found that for the oncology therapies bevacizumab, rituximab, and trastuzumab, hospitals profited handsomely from the use of biosimilars over their reference products. Their study was published March 11 in JAMA.

From 2020 to 2024, the hospitals’ uptake of bevacizumab jumped from 32% to 93%. Similar leaps were seen for trastuzumab biosimilars (from 37% to 87%) and for rituximab biosimilars (from 18% to 84%). — Adapted from Robinson et al. *JAMA* March 2026

The overall biosimilar uptake of these three products has been a model for the rest of the biosimilar industry in that uptake was rapid (achieving >60% utilization by year 3) and > 60% average sales price (ASP) declines occurred over four years. These biosimilars first entered the market in 2019. According to the Samsung Bioepis Biosimilar Trend Report, ASPs have now dropped below $1,000 for several biosimilars in all three drug categories, with the most extreme drop for Trazimera, a biosimilar of trastuzumab, at an ASP of $112 per 420 mg dose. Biosimilar uptake is over 85% for the bevacizumab and trastuzumab categories and at 78% for rituximab.

Biosimilar Acquisition Prices Dropped, Hospital Profit Rose

The researchers collected data from Blue Cross Blue Shield health insurance plans that contained drug acquisition costs, drug reimbursements by the insurers, hospital eligibility for 340B discounts, and other information from 2020 to 2024. The database covered more than 66,000 patients who received oncology biologics and biosimilars in more than 1500 hospitals.

They found that the biosimilar acquisition prices paid by the hospitals to manufacturers (or intermediaries) declined by 60% for bevacizumab, 72% for trastuzumab, and 63% for rituximab over that period. However, reimbursements from insurers declined only by 32%, 36%, and 34%, respectively, resulting in additional profit for the hospital systems.

With the increased profit from these three oncology biosimilar categories, the hospitals increasingly favored the biosimilars over the reference biologics. From 2020 to 2024, hospital uptake of bevacizumab jumped from 32% to 93%. Similar leaps were seen for trastuzumab biosimilars (from 37% to 87%) and for rituximab biosimilars (from 18% to 84%).

These figures would seem counterintuitive, if one considers the pervasive 340B discounts used by hospital systems for outpatient drugs. The authors assumed a 340B discount of 65% of the ASP price. If that is factored in, it would make most sense for the hospital system to purchase at the low 340B price, and seek reimbursement from insurers at the higher price, further widening their profit on each drug utilized. The researchers found that “Hospitals eligible for federal 340B acquisition price discounts were associated with a lower probability to adopt biosimilars than noneligible hospitals for trastuzumab and rituximab.” They also found that “for-profit hospitals were associated with higher probability of biosimilar use for trastuzumab and rituximab.

The study authors believe that gainsharing or shared-savings payment methodologies by Medicare accounted for the overall preference for biosimilars. These gainsharing payment methods, they assert, have also become popular in the private sector as well.

This experience may well be applied to the new oncology biosimilars that will be introduced for Keytruda, Opdivo, and others over the next two to three years.

In Other Biosimilar News

Celltrion announced that its tocilizumab biosimilar (Avtozma) has been launched in the US, marking the first intravenous and subcutaneous biosimilar interleukin-6 receptor antagonist. It is one of three Actemra biosimilars approved in the US.

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.

Two Leaders’ Views on National PBM Reform: Biosimilar and ERISA Benefits

A summary of remarks on PBM reform and the FTC–ESI settlement by speakers at last month’s Association for Accessible Medicines’ Access 2026 conference.

The Association for Accessible Medicines’ (AAM) Access 2026 conference in Miami February 23-25 was perfectly timed to take advantage of perhaps the most important health care—related events of the year: the passage of the Consolidated Appropriation Act’s pharmacy benefit manager (PBM) reforms and the Federal Trade Commission (FTC) settlement with Express Scripts (ESI), which almost certainly will lead to agreements with the other big 3 PBMs. In two sessions at AAM, two main players in shaping PBM reform over several years discuss their reactions and expectations.

On the Long Road to PBM Rebate Changes With Scott Gottlieb

Scott Gottlieb, MD, former FDA Commissioner during the first Trump administration, was part of the effort to enact its Biosimilar Action Plan to nudge biosimilar uptake in the right direction. Another of the pro-biosimilar efforts by he and then Secretary of Health and Human Services Alex Azar was the planned removal of safe harbor protection for drug rebates. Though some of these efforts made it to the finish line, the use of drug rebates to ensure PBM profits and to disadvantage lower-priced pharmaceuticals survived their attempts. At the AAM conference in Miami last week, Dr. Gottlieb restated, “If there was ever PBM actions that can prove their anticompetitiveness, this is it!”

Scott Gottlieb believes additional PBM reform is unlikely, though we may not have gone far enough — Scott Gottlieb

Dr. Gottlieb believes that “you can take the entire construct we made, tailor it to just these circumstances today. The cost of implementing the rule [to remove the rebate safe harbor] will save money in this narrow biosimilar application.”

Lacking that, he still believes that the settlement between the FTC and ESI “was profound. The issues of the rebates flowing back to consumers, the writing’s on the wall. A lot of the changes are happening absent legislation action.” However, he believes that with the reforms achieved through the Consolidated Appropriations Act of 2026 and the FTC–ESI settlement, “additional PBM reform is unlikely, though we may not have gone far enough,” said Dr. Gottlieb. Still, he believes that CMS can take additional action, in the way it directs companies to design formularies.

ERISA Employers Can Celebrate Freer PBM Markets

A jubilant James Gelfand, JD, President and CEO, The ERISA Industry Committee (ERIC), exclaimed, “We won! We’ve forced transparency on the PBMs, forced pass-through rebates, and we’re ready to celebrate. This will make it very hard for PBMs to make money on arbitrage. We think it’s transformative.”

Mr. Gelfand noted that Congress is still considering additional changes, one of which is to address the request-for-proposal process. This is necessary because of the cozy relationship between the big PBMs and the employer benefit consultants and brokers. “If the PBMs are in cahoots with the brokerage/consulting companies to keep their business, it will make it very hard for these other PBMs to come in with innovative models and to apply fiduciary standards,” he said.

The PBMs have said that employers love rebates, according to Mr. Gelfand, saying they go to the company’s bottom line. ERISA rules prohibit this: “We can’t use the rebates for anything but to reduce healthcare costs.”

We’ve forced transparency on the PBMs, forced pass-through rebates — James Gelfand

After these reforms are applied, 98% of our employer members still see a role for PBMs, he said. “We don’t want to get into the PBM business.”

Free markets need competition, information, and choice. The rebate pass-through provision is the most important of the reforms. His organization, ERIC, has been advocating for PBMs for many years. Mr. Gelfand remarked, in the Consolidated Appropriations Act of 2021, “we got a provision in place that aimed at revealing the compensation of the vendors that work for employers in employer-sponsored health benefit plans. The Department of Labor interpreted that to mean just brokers and consultants. But from the beginning, we had intended this to also include PBMs. Legislators sent letters to the Department of Labor, telling them they forgot to include PBMs. It took another 5 years to get this changed.”

PBMs and Employer Benefit Consultants: Only a Minor Conflict of Interest?

Employers take advice from consultants and brokers, who help them choose their PBM. They help them decide whether they should be part of a purchasing collaborative, or whether they should contract directly with pharmaceutical companies. “Yet, these third parties are getting paid by the PBM, which makes it not very reliable advice,” asserted Mr. Gelfand. “And we have the same issue with the PBM who tells us, ‘Trust us, you want to go with the AbbVie drug, it’s been out for years, it’s reliable, and the rebate is awesome!’ If I ask them how much of a rebate they receive, they say, ‘We’re not going to tell you that. It’s not important.’”

The Department of Labor will have to unravel the gordian knot of how PBMs profit, opening the employer’s eyes to how PBMs are earning their money. “Employers pay 75 cents out of every health care dollar, so it’s a big deal if we’re being steered towards the higher-priced product. We’ve been ‘trusting’ the PBMs for decades that we’ve been getting the lowest net-cost drugs. But it can’t be explained to us exactly how it’s the lowest net-cost product.”

Instead, the PBM responds, “You have to look across the entire book of business, because having this drug and its bundled rebate is complicated and can’t be easily explained to you.” Mr. Gelfand believes it may be 18 months before a final rule is released by the Department of Labor, but “all that is going to be over.”

We can’t effectively legislate against specific behaviors of the PBM (like spread pricing or rebates) because of the time it takes to pass a Congressional proposal. “The PBMs have very smart people and will always be a step ahead of us, and maybe three steps ahead of Congress because they are so slow to act,” said Mr. Gelfand. “Fundamentally, you can’t just keep going after these rifle shots to legislate their behavior. You must legislate a new business model or paradigm, or they will find ways to get around it. That’s why we think PBMs should be fiduciaries. As a fiduciary, you cannot just invent new ways to cheat your customer. Under ERISA, fiduciaries cannot waste money under the plan, and they must make decisions that are prudent and in the best interests of the beneficiaries of that plan. There’s no way to fit these nasty arbitrage tricks under these two rules. Unfortunately, we’re probably years away from getting this done.”

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.