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.

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.

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.”

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.

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.

Samsung Bioepis Reinforces Its Biosimilar Pipeline

For biosimilar industry watchers like BR&R, Samsung Bioepis has played a leading role in introducing biosimilars to the US market, first with its infliximab biosimilar Renflexis. Over the years, as their biosimilar candidates were approved by the FDA, the pipeline appeared to thin, with pembrolizumab (SB27) being the sole publicly disclosed biosimilar candidate, as of the beginning of this week.

That changed very suddenly on January 15, when Samsung Epis Holdings, the parent of Samsung Bioepis, announced a healthy new slate of biosimilar candidates in early-stage development. The six additions to the pipeline include:

Dupilumab (reference product, Dupixent) (earliest main patent expiration, 2031)
Guselkumab (Tremfya) (2031)
Ixekizumab (Taltz) (2030)
Vedolizumab (Entyvio) (2028)
Ocrelizumab (Ocrevus) (2029)
Fam-trastuzumab deruxtecan (Enhertu) (2033)

When queried by E-mail, Samsung Bioepis added that each of these biosimilar candidates were developed in-house and were not licensed from other biopharmaceutical companies.

In the announcement, Kyung-Ah Kim, President and CEO of Samsung Epis Holdings, stated, “We are making great progress to secure 20 biosimilars in our portfolio by 2030.”

In addition to the newly announced biosimilar pipeline, Samsung Bioepis also updated its efforts to produce novel therapeutics. These include an antibody conjugate (SBE303) for oncology indications, which is entering phase 1 trial. This investigational innovator agent was partly the result of a global partnership with Phrontline Biopharma. The company intends to introduce “one novel therapeutic candidate into clinical study every year.”

(Editor’s Note: The anticipated patent expiration dates are obtained through multiple sources, based on composition-of-matter patents. However, patent litigation that delays commercialization may extend beyond these principal patents.)

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.

The Next Set of Biologics for Medicare Price Negotiations Predicted (and Eliminated?)

With this first post since the holidays, there is so much to discuss, yet so little firm ground on which to anchor the discussion. Since December 23, the Trump administration has added two more drug pricing reform models to the gordian knot of US pharmaceutical reimbursement, and authors from the University of Washington School of Pharmacy have published their list of drugs anticipated to be subject to Medicare price negotiation for year 3.

In this article, we’ll unpack the latter first, because it is straightforward (sort of). Based solely on Medicare expenditures and market exclusivity expiration, the researchers published in the Journal of Managed Care and Specialty Pharmacy what they believe will be the next round of drugs to be subject to Medicare price negotiation this year, for implementation January 1, 2028. The Table below lists the following biologics (of 15 identified drugs in total).

TABLE: POTENTIAL BIOLOGICS FOR MEDICARE PRICE NEGOTIATION IN 2026 FOR 2028 IMPLEMENTATION

Reference Product Brand Name	Nonproprietary Name	US Biosimilar Candidates Publicly Disclosed?*	Potential Launch of Biosimilars
Trulicity	Dulaglutide	Possible†	≥ 2030
Orencia	Abatacept	Yes (≥ 2)	≥ 2028
Entyvio	Vedolizumab	Yes (≥3)	≥ 2028
Cosentyx	Secukinumab	Yes (2)	2027
Xolair	Omalizumab	Yes (≥5)	2026
Cimzia	Certolizumab	Yes (≥1)	2027
Botox	Onabotulinumtoxin A	Possible†	N/A
Simponi	Goliumumab	Yes (2)	2026/2027

Number of existing candidates indicated in parentheses. Some manufacturers have indicated work on several upcoming biosimilars, without specifying individual molecules. Therefore, the existence of undisclosed candidates must be considered. †One Chinese dulaglutide candidate identified, but may not be intended for US market. Previous Botox candidate was announced pre-2020, but no updated information exists. Sources: Cousin EM, Martin K, Hansen RN, et al. J Manag Care Spec Pharm*. 2026;32(1):3-13; BR&R research.

This sunset of drugs represents the first time several biosimilar targets are included (as it is the first inclusion of part B drugs). Almost all drugs in the Table are covered to an extent under both part B and D. Indeed, the vast majority are currently the subject of biosimilar development. Some of these biosimilars will likely launch prior to 2028, before the negotiated Medicare price takes effect. Of course, predicted launch dates are dependent on patent settlements. The authors point out that other drugs are left off the list because their biosimilars are already marketed (e.g, aflibercept and denosumab) or eligibility is delayed by orphan drug rules (e.g., pembrolizumab and nivolumab, which will be eligible for selection in 2027).

If the Centers for Medicare and Medicaid Services (CMS) determine that a biosimilar launch is imminent, a request for delay in eligibility will be considered. However, CMS may seek negotiated prices if a request is not submitted, as occurred with ustekinumab. This will likely shrink the potential biosimilar revenues for these individual products. The reason CMS targets these products is that they are blockbusters. That is also the reason biosimilar manufacturers are interested in these biologics. With Medicare paying about one-third less for these agents in 2028 before biosimilar approval is obtained, they will be less interested in commercializing those agents. Consider the potential for limited market share (e.g., adalimumab), expensive patent litigation battles (e.g., nearly all products), and opportunity costs (i.e., against developing their own proprietary branded products).

Furthermore, if the ustekinumab experience is any reference, the negotiated Medicare Fair Price (MFP) will be well above the price that results from competition with several agents. The FDA is actively seeking to remove late-phase comparative trial requirements in an effort to lower development costs and reduce time to commercialization.

Today, it may make sense to modify CMS’s criteria for determining whether biosimilar launch is imminent. If a biosimilar product is already approved by FDA, this should take the reference product off the table for MFP eligibility. If three or more biosimilar products are actively in development (i.e., with FDA consultations or early-stage trials in progress) that should also eliminate the reference product from eligibility. I define three drugs as the threshold, because it should encourage significant price competition.

Drug payment and approval policies in this administration are moving all at once. We’ll review the latest salvo from CMS in the next post. However, with several biologics on the MFP list, the administration should review exactly what the value of biosimilar competition really is and how then to preserve it.