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WHEN CHOICE ARRIVES: Competition & Consequences

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Articles

Ashley Gallagher is an associate editor for Pharmacy Times.

Bipartisan bills would automatically delay Medicare price talks for biologics facing biosimilars as California expands substitution.

Biosimilar Bills Would Automate Medicare Negotiation Delays

Videos

Robert Cook, PhD, of Teva explains how analytical characterization and PK data will shape its next biosimilar program.

How FDA's PK Guidance Shapes Teva's Next Biosimilar Program

Teva's Robert Cook, PhD, explains the clinical data, interchangeability, and supply strategy behind its Degevma and Ponlimsi biosimilars.

Inside Teva's Denosumab Biosimilar Strategy: Robert Cook, PhD

Laura Joszt, MA, is the vice president of content for the managed care and pharmacy brands at MJH Life Sciences

. She has been with MJH Life Sciences since 2011.

Laura has an MA in business and economic reporting from New York University.

The FDA approved Teva's Degevma, a denosumab biosimilar to Xgeva for cancer-related bone disease, rounding out its Xgeva/Prolia portfolio.

Teva Completes Denosumab Biosimilar Pair With FDA Nod for Degevma

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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Edward Li, PharmD, is the Head of Health Economics and Outcomes Research at Sandoz. 

Sandoz's Edward Li explains how biosimilar denosumab pricing could reshape cost-effectiveness, payer access, and gaps in osteoporosis care.

Biosimilar Denosumab Could Reshape Access, Costs in Osteoporosis Care: Edward Li, PharmD

The FDA has approved denosumab-adet (Degevma; Teva Pharmaceutical Industries), a biosimilar to Xgeva (denosumab; Amgen), across all indications of the reference product, Teva announced September 28, 2026.

Degevma is indicated to prevent bone complications in adults with advanced cancer that has spread to the bone, to treat adults and skeletally mature adolescents with giant cell tumor of bone, and to treat hypercalcemia of malignancy.

Degevma Rounds Out Teva's Denosumab Biosimilar Portfolio

Degevma is Teva's second FDA-approved biosimilar of 2026. It follows the March approval of denosumab-adet (Ponlimsi), a biosimilar to Prolia (denosumab; Amgen) for postmenopausal osteoporosis and the reference product's other indications. Together, the 2 products give Teva a denosumab biosimilar portfolio spanning both oncology-related bone disease and osteoporosis care.

“Teva has a long history of bringing such complex products to market; together with Ponlimsi as the Denosumab portfolio, these products offer you very high batch-to-batch consistency,” Robert Cook, PhD, head of generics R&D and SVP of global technical development at Teva, said in an interview with The Center for Biosimilars. 

The approval was based on a totality of evidence, including analytical and clinical data demonstrating an efficacy, safety, and immunogenicity profile similar to that of Xgeva, with no clinically meaningful differences in safety, purity, and potency. Like its reference product, Degevma is a human monoclonal antibody that binds to RANKL, a protein essential to the formation, function, and survival of osteoclasts. By inhibiting RANKL, it decreases bone resorption and cancer-induced bone destruction. Degevma will be available as a 120-mg/1.7-mL solution for injection in a vial, and Teva anticipates launching both Degevma and Ponlimsi in the US in the coming months.

With this approval, 10 companies now hold FDA approval for denosumab biosimilar pairs referencing both Xgeva and Prolia. Each company's pair shares a single nonproprietary name; Ponlimsi and Degevma, for example, are both denosumab-adet.

“It helps to submit [denosumab-adet] as different products to have seamless integration with clinical practices and also the payers that are acquiring these molecules for the patients,” Cook said. 

Denosumab Biosimilar Value Hinges on Price and Payer Access

Degevma's indications center on cancer-related bone disease. One of the first economic evaluations of a denosumab biosimilar, however, focused on osteoporosis, the indication of the Prolia-referencing products. That cost-utility analysis found that biosimilar denosumab was likely to be cost-effective against 4 bisphosphonates for women with postmenopausal osteoporosis at high fracture risk, at a willingness-to-pay threshold of $150,000 per quality-adjusted life-year (QALY). The margin was thinnest against zoledronic acid, with an incremental cost-effectiveness ratio of $144,995 per QALY gained and cost-effectiveness in just 55.4% of simulations.

At a $100,000 threshold, only the comparison with risedronate held up, while alendronate and ibandronate narrowly missed it. The model assumed the biosimilar's price at 80% of reference denosumab's cost, a hypothetical figure because no US price was available at the time, and the results were sensitive to it.

More than 2 million osteoporosis-related fractures occur annually in the US, and direct and indirect costs are projected to climb from $57.0 billion in 2018 to more than $95.2 billion by 2040.

Sandoz's denosumab-bbdz (Jubbonti), the first FDA-approved denosumab biosimilar, was approved in March 2024 and launched in June 2025. Sandoz positioned it as a lower-cost option intended to expand patient access. 

Whether lower prices lead to broader access will ultimately be up to payers, said Edward Li, PharmD, corresponding author of the analysis and head of health economics and outcomes research at Sandoz, when he discussed the findings in an interview with The Center for Biosimilars.

"The question is no longer whether the biologic works but whether the economic rationale for limiting access remains the same once biosimilar competition enters the market," he said. "Ultimately, payers will decide whether lower costs warrant broader access, but those decisions should be informed by an updated understanding of the therapy's value in the current marketplace."

Li added that demonstrating cost-effectiveness does not automatically translate into adoption. For payers, he said, the key question is whether lower costs lead to changes in coverage policies and utilization management requirements, and patients benefit only if that improved value shows up as fewer access barriers and broader access to treatment.

"Even if cost barriers come down, there is still work to do to identify appropriate patients, initiate treatment, and keep them on therapy," Li explained. "Ultimately, improving patient access will require both payer and provider stakeholders to recognize how the value proposition has changed with biosimilar competition."

Degevma adds another option to an increasingly crowded denosumab market, though Teva framed its purpose around patients.

"The last thing a person living with a cancer diagnosis or their families should have to worry about is access to their medicine," Thomas Rainey, senior vice president of US Biosimilars at Teva, said in the news release.

Teva continues biosimilar momentum with U.S. FDA approval of DEGEVMA (denosumab-adet), a biosimilar to Xgeva (denosumab). News release. Teva Pharmaceutical Industries. September 28, 2026. Accessed September 29, 2026. 

https://www.tevapharm.com/news-and-media/latest-news/teva-continues-biosimilar-momentum-with-u.s.-fda-approval-of-degevma-denosumab-adet-a-biosimilar-to-x

McCrear S. FDA approves Teva biosimilar for denosumab in osteoporosis. The Center for Biosimilars. March 31, 2026. Accessed September 29, 2026. 

https://www.centerforbiosimilars.com/view/fda-approves-teva-biosimilar-for-denosumab-in-osteoporosis

Jeremias S. Biosimilar denosumab shows cost-effectiveness over bisphosphonates in PMO. The Center for Biosimilars. August 4, 2026. Accessed September 29, 2026. 

https://www.centerforbiosimilars.com/view/biosimilar-denosumab-shows-cost-effectiveness-over-bisphosphonates-in-pmo

McCrear S, Li E. Biosimilar denosumab could reshape access, costs in osteoporosis care: Edward Li, PharmD. The Center for Biosimilars. September 1, 2026. Accessed September 29, 2026. 

https://www.centerforbiosimilars.com/view/biosimilar-denosumab-could-reshape-access-costs-in-osteoporosis-care-edward-li-pharmd

Clinical

Business & Practice

Approvals Launches

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, shared her insights on future biosimilar development amidst recent FDA approvals and policy changes.

In an interview with The Center for Biosimilars

 (CFB), Jensen expanded on how recent changes in the biosimilar landscape might affect payers and patients.

This transcript was lightly edited for clarity. 

CFB: Given that roughly 90% of biologics coming off‑patent may lack a biosimilar, what proactive strategies should health systems adopt now to safeguard patient access and cost containment?

 From a health system perspective, this is a really challenging area because, as costs stay high, reimbursement might not always cover that medication expense from a health system perspective. I think for health systems to keep providing care without taking on major losses, we need to have effective site-of-care management strategies in place and strong contracting skills. The most cost-effective strategy for health systems may be to join forces and advocate with manufacturers, nonprofits, and coalitions to develop biosimilars, especially where spending is high and competition is limited. 

Additionally, I do think incentives are needed to encourage biosimilar development and help lower the overall cost of health care. This could require financial support from the federal government and nonprofit organizations.

It is promising to see that there has been a recent legislative change and efforts aimed at reducing biosimilar development costs by limiting some of those comparative effectiveness studies, especially when that robust analytical data is there to support it. However, I think challenges will still remain, since it is still quoted that the cost to develop a biosimilar in the US ranges anywhere from $75 million up to $250 million.

I think we do have a way to go, from a health care system perspective; the best we can do is create those coalitions so we can try to incentivize the development of biosimilars in some of those vacant categories.

 simplifies analytical comparability and clinical bridging. Which specific elements do you think will most accelerate time-to-market for future biosimilars?

The advancement of analytical technologies that are able to detect those differences or similarities with greater accuracy, and when combined with expanded access to sensitive measurement tools, will enhance the reliability of that analytical data. This improvement is expected to diminish the reliance on those in human trials and therefore reduce or lower the development costs. By having these superior technologies, we should be able to see earlier submissions of biologic license applications (BLAs), potentially leading to expedited approvals and accelerated markets.

 of multiple denosumab biosimilars in a single year shows rapid market expansion. What lessons can be drawn from that experience for upcoming biosimilar launches in other high-revenue biologics?

The recent guidance update that removed the requirement for the comparative effectiveness switching studies to achieve interchangeability designations does mark significant progress and has positively impacted the denosumab category, likely encouraging greater adoption. I think this category is particularly noteworthy as well, because denosumab is predominantly a medical benefit drug, though there might be some pharmacy benefit coverage as well, and it mainly affects older adults, where we see more government-insured, Medicare, or Medicare Advantage payer populations.

Here at Mayo Clinic, we're really focused on learning how we can more effectively manage biosimilar switches and biosimilar adoption by utilizing our electronic health record tools and exploring ways to enhance category flexibility through the electronic health record moving forward; meaning, with the product we change, how can we rapidly incentivize and do proactive conversion? And when we do have that flexibility down the road, should the contract change while we're still under negotiation in this category?

I do suspect that most health care institutions may choose to contract with 1 manufacturer for both Prolia and Xgeva (denosumab; Amgen) biosimilars. However, because there's such strong competition in this category, it could be that we select one manufacturer for its Prolia biosimilar and another manufacturer for its Xgeva biosimilar, also in this category. It's not new, because Prolia and Xgeva have always shared the same Healthcare Common Procedure Coding System code. We are seeing that same trend with the biosimilars.

However, there’s still a need to keep a pulse on this, making sure that we're not running into any downstream billing errors and denials because of that shared fixed code. [We should continue] to rely on that provider education and how we build these on the electronic health record to make sure that we are selecting the appropriate product for the appropriate indication.

CFB: When several biosimilars compete for the same reference product, what criteria (clinical data, pricing, real-world evidence, patient-support programs) become most decisive for formulary placement at Mayo Clinic?

At Mayo Clinic, at this stage, we really have a high level of confidence in the clinical data coming from the process for a vast majority of the biosimilar assets. I think the final decision will likely depend on factors such as supply resiliency, manufacturer reputation, and history and pricing, because in the denosumab categories, specifically, this is a heavy government population, and I don't think co-pay assistance really plays a role here, as we know that many of our government programs are exempt from co-pay assistance for assistance programs.

However, other categories that are coming out, like omalizumab, Xolair biosimilars, natalizumab, and Tysabri biosimilars, do have a higher volume of commercially insured populations, and therefore copay assistance and payer coverage are some aspects that I do expect would be important considerations for those categories, but not really a focus for the denosumab category.

CFB: What early warning signals does Mayo Clinic monitor to anticipate a ‘biosimilar void’ for a specific reference product, and how do those signals shape your formulary strategy?

Where we're really pivoting here at Mayo Clinic is [finding] a more robust way to monitor the financial performance and outcomes of our whole drug portfolio. We really worked on internal tools to track our drug costs, our reimbursement, and broader financial trends more efficiently. That way, we can determine where we are having reimbursement issues, and we're able to dig in. Is this due to a denial or to a prior authorization issue that maybe we can update within the electronic health record, or [something to] discuss with our providers? Or is this because our reimbursement is simply not covering our costs? Therefore, is the average sales price far below what we have to purchase the drug at?

When we get into those later line agents, of course, we'll try to negotiate and try to get better pricing on the drug, but this is where we're really seeing that biosimilar void. I know we can't get any better pricing. I know this drug is off patent, and we don't have any competition coming. And that's really where we have to have some of those other harder discussions, saying, What else can we do in this category? Could we potentially start partnering with a coalition (eg, Cost Plus, Civvica) or some of our other coalitions to really incentivize the development of these drugs?

Lowering that development cost because of the greater good that we need this type of drug in the US market, and that's where we're going. Where I think this biosimilar void does factor in is if we're not seeing any competition. This is really where healthcare institutions may have to make difficult decisions to move these drugs out to 340B facilities, or if they're an orphan drug, disproportionate share hospitals, and that's where access really could get limited for patients, and that's really where I hope we don't have to go in the market. But I’m sure that is where some health care institutions currently are in decisions that they might be facing right now.

Mayo Clinic’s Chelsee Jensen, PharmD, discusses FDA policy changes, biosimilar development hurdles, denosumab lessons, and payer access strategies.

Q&A With Chelsee Jensen, PharmD: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026

Stakeholders across the US health care system navigated a maturing biological market that reached a significant milestone of 90 total approvals by the end of 2025.

 This progress, detailed in a recent industry report from Samsung Bioepis, highlighted how the biosimilar sector moved beyond early-stage growth into a complex era of high market penetration and shifting financial incentives.

As of December 2025, the FDA had cleared biosimilars for 20 unique biological molecules, with 63 of those 90 approvals (70%) successfully reaching the commercial market. These launches led to substantial price reductions over time; on average, the average sales price for biosimilars decreased by 52% within 5 years of the initial class launch. In more mature therapeutic areas, these price reductions reached as high as 77%.

Market adoption patterns revealed a distinct divide between "fast" and "slow" uptake markets. Oncology, ophthalmology, and pegfilgrastim biosimilars were categorized as fast-uptake products, achieving an average market share of 81% within 5 years of launch. In contrast, sectors such as immunology, filgrastim, and insulin glargine saw much slower adoption, averaging only a 25% market share in the same timeframe. By the third quarter of 2025, specific molecules like bevacizumab and trastuzumab reached biosimilar market shares of 92% and 88%, respectively.

Despite these gains, the industry faced significant issues regarding traditional pharmacy benefit management (PBM) contracting. Historically, the PBM model favored high-wholesale acquisition cost (WAC), high-rebate products because those products contributed more heavily to the "rebate guarantees" that PBMs promised to self-funded employers. This structure created a "rebate trap" where a lower-cost biosimilar might have a lower net price than the reference biologic but was excluded from formularies because it did not provide the necessary rebate volume to satisfy aggregate contractual guarantees.

In 2026, however, the report pointed to a critical shift toward fiduciary and transparent PBM models. These emerging frameworks prioritized trend management and cost control over rebate maximization. Some PBMs introduced "rebate credits," which allowed the price difference between a reference product and a biosimilar to count as a "phantom credit" toward rebate guarantees, effectively removing a major barrier to biosimilar adoption.

Thomas Newcomer, vice president and head of US commercial operations at Samsung Bioepis, commented on these systemic changes in the report's press release: “As the US healthcare market enters 2026, stakeholders’ approaches to prescription drug pricing and management continue to evolve. Alongside established PBM contracting structures, new models emphasizing alternative pricing reimbursement, transparency, and a shift towards more fiduciary responsibility have emerged in response to changing market conditions.”

Specific therapeutic areas also faced unique challenges as 2026 began.

 In the ophthalmology space, although 4 aflibercept biosimilar products are awaiting clearance to launch, the reference product faces only 1 competitor offering a 12% WAC discount. Meanwhile, the immunology sector saw a proliferation of complex pricing strategies; while private label brands became common for adalimumab and ustekinumab, most ustekinumab manufacturers avoided the dual "high WAC/low WAC" strategy that characterized the adalimumab market in previous years.

Looking forward through 2026, the continued erosion of reference product dominance appeared likely as PBMs pledged fuller rebate pass-throughs by 2028 and more employers adopted biosimilar-first strategies.

 These shifts suggested that the primary challenge for the industry was no longer demonstrating clinical parity but rather aligning financial incentives to ensure that the most cost-effective therapies reached the patient.

Biosimilar approvals. The Center for Biosimilars

. Updated December 22, 2025. Accessed January 27, 2026. 

https://www.centerforbiosimilars.com/biosimilar-approvals

SAMSUNG BIOEPIS: Biosimilar market report 12th edition, Q1 2026. January 23, 2026. Accessed January 27, 2026.

Samsung Bioepis releases Q1 2026 US biosimilar market report. News release. Samsung Bioepis. January 23, 2026. Accessed January 27, 2026. 

https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=531&currentPage=1

Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed January 27, 2026. 

https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

The US biosimilar market evolves with 90 approvals, significant price drops, and new PBM models enhancing access to cost-effective therapies.

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

Qilu Pharmaceutical, Mabpharm, Bio-Thera Solutions

Henlius, Innovent Biologics, Bio-Thera Solutions

Test your knowledge of biosimilar approvals in China.

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Poll: How Much Do You Know About Biosimilars in China?

Efforts to expand access to vision-saving therapies for people with diabetic eye disease increasingly depend on the availability of lower-cost biologic alternatives, and new comparative data add clarity to how one aflibercept biosimilar performs in routine clinical practice. A recently published retrospective analysis evaluated whether the aflibercept biosimilar QL1207 offered similar outcomes to reference aflibercept for individuals with diabetic macular edema (DME), a leading cause of vision impairment among people with diabetes.

The study was conducted to address a longstanding gap in real-world data. Although QL1207 was approved by China’s National Medical Products Administration in late 2023 based on structural and functional similarity to reference aflibercept, published comparative clinical information in DME populations remained limited. 

Given the high cost of originator anti-VEGF therapy and the chronic, injection-intensive nature of DME management, the investigators sought to determine whether the biosimilar performed comparably in anatomical and functional outcomes, macular perfusion metrics, injection burden, and safety.

The analysis included anonymized clinical data from 80 adults (80 eyes) with nonproliferative diabetic retinopathy and DME who were seen at a single ophthalmology department between June 2023 and April 2024. Participants were treatment-naïve and met diagnostic criteria outlined in the American Academy of Ophthalmology’s 2019 clinical guidelines. Individuals were excluded if they had other retinal diseases, a history of ocular procedures, proliferative disease, significant media opacity, or a hemoglobin A1c greater than 7%.

Demographic characteristics were balanced across treatment groups. The reference aflibercept group included 40 people (20 men and 20 women) with a mean age of 48.6 years. The QL1207 group included 40 people (19 men and 21 women) with a mean age of 46.7 years. Baseline HbA1c levels were similar, and no clinically meaningful differences emerged during the 12-month follow-up period.

All participants received 3 monthly loading doses followed by a pro re nata retreatment approach. Retreatment criteria included central retinal thickness (CRT) greater than 280 µm or a decrease of 5 or more Early Treatment Diabetic Retinopathy Study letters. Best-corrected visual acuity (BCVA), optical coherence tomography measures, and optical coherence tomography angiography parameters—including foveal avascular zone (FAZ) area and superficial and deep vascular density (SVD and DVD)—were collected at baseline and during follow-up. The investigators also recorded injection frequency and adverse events.

The study found no statistically significant differences between groups in BCVA or CRT at baseline or at 1, 3, 6, or 12 months. Both groups demonstrated significant improvement in BCVA relative to their own pretreatment values, as well as substantial reductions in CRT (

 < .05 for all within-group comparisons). At 12 months, mean CRT decreased from 447.1 µm to 280.4 µm in the reference group and from 441.0 µm to 290.3 µm in the QL1207 group. Injection burden was also similar, with mean injection counts of 3.58 in the reference group and 3.40 in the biosimilar group (

Macular microvascular outcomes also aligned closely across groups. FAZ area decreased significantly within each group, while both SVD and DVD increased, indicating improved or stabilized macular perfusion. None of these parameters differed significantly between groups at baseline or month 12.

Safety outcomes were consistent with the known safety profile of intravitreal anti-VEGF therapy. Mild events—including transient intraocular pressure elevations, corneal epithelial damage, and subconjunctival hemorrhage—occurred infrequently and at similar rates in both groups. No individuals experienced endophthalmitis, glaucoma, vitreous hemorrhage, cataract progression, or systemic cardiovascular or cerebrovascular events during the follow-up period.

The authors noted several limitations, including the retrospective design, relatively small sample size, nonrandomized treatment assignment, and 12-month follow-up period. In addition, while statistically significant changes in OCT angiography parameters were documented, their clinical significance remains uncertain. Longer, prospective, randomized studies will be needed to validate long-term comparability between QL1207 and reference aflibercept in DME.

Even with these limitations, the findings contribute to growing real-world evidence showing that aflibercept biosimilars may offer an effective and potentially more affordable option for individuals living with DME. As biosimilar adoption grows globally, studies like this may help inform formulary decisions and support broader access to sight-preserving therapy.

Zhai G, Liu N, Wang S, Zhang X. Comparative efficacy of intravitreal aflibercept biosimilar QL1207 versus reference aflibercept in the treatment of diabetic macular edema. 

. 2025:12:1662735. doi:10.3389/fmed.2025.1662735

Edward Li, PharmD

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