Sabrina McCrear

Denosumab-adet (Ponlimsi; Teva Pharmaceutical Industries) was approved by the FDA as a biosimilar to treat postmenopausal women with osteoporosis, in addition to all other indications of the reference product, Prolia (denosumab; Amgen Inc).

The approval of denosumab-adet was based on evidence that demonstrated a similar efficacy, safety, and immunogenicity profile compared with the originator. Denosumab-adet is also approved to treat postmenopausal women with osteoporosis with a high risk of fracture to increase bone mass, women with a high risk of fracture receiving adjuvant aromatase inhibitor therapy for breast cancer to increase bone mass, men with osteoporosis with a high risk of fracture, and men with a high risk of fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. 

The European Medicines Agency (EMA) granted Teva marketing authorization for denosumab-adet in November 2025 after a positive review from the Committee for Medicinal Products for Human Use in early 2025.

Teva secures FDA approval for a biosimilar targeting osteoporosis. | Image Credit: gguy - stock.adobe.com

Denosumab products are human monoclonal antibodies that bind to RANKL, preventing RANK receptors on the surface of osteoclasts from activating and causing osteoclastic bone reabsorption.

There are more than 10 million adults in the US over the age of 50 with osteoporosis, of whom more than 80% are women. Approximately 1 in 2 women and 1 in 4 men will experience an osteoporosis-related fracture, decreasing quality of life and increasing the likelihood of disability and death.

The approval of denosumab-adet adds to a growing list of denosumab biosimilars expanding access in a competitive landscape for biosimilar therapies targeting bone health and cancer-related skeletal events.

Commonly reported adverse events with denosumab products—occurring in more than 5% of patients taking them for postmenopausal osteoporosis and more common than placebo—included back pain, pain in the extremity, musculoskeletal pain, hypercholesterolemia, and cystitis.

The most common adverse reactions reported in men with osteoporosis—accounting for more than 5% of patients—were back pain, arthralgia, and nasopharyngitis. 

Additionally, Teva’s applications for a proposed biosimilar to the reference product Xolair (omalizumab; Novartis AG) were accepted by the US FDA and the EMA to treat allergic asthma.

Xolair is a humanized monoclonal antibody targeting IgE, preventing it from activating cells that trigger allergic reactions. Allergic asthma is the most common form of asthma. Individuals with allergic asthma can be triggered by harmless substances, causing the airways of the lungs to become inflamed and swollen. Adverse events include coughing, wheezing, shortness of breath, and tightness in the chest. 

“Our biosimilars R&D engine continues to demonstrate its depth and maturity. By combining deep internal expertise with strategic partnerships, we’re building a highly competitive portfolio,” Steffen Nock, PhD, head of biosimilars research and development and chief science officer at Teva, said in a 

Biosimilars are expected to play an increasingly important role in improving affordability and access to biologic therapies in the US. By introducing lower-cost alternatives to reference products, biosimilars may help reduce overall health care spending while expanding treatment availability. For payers and providers, the growing availability of biosimilars also introduces new considerations around formulary placement, interchangeability, and patient access strategies.

Together, these developments bring “significant potential to address patient needs and fuel Teva’s long-term growth,” Nock said. 

1. Teva gains biosimilar momentum with U.S. FDA approval of PONLIMSI (denosumab-adet) and dual filing acceptance for biosimilar candidate Xolair (omalizumab). News release. Teva. March 31, 2026. Accessed March 31, 2026. 

https://www.tevapharm.com/news-and-media/latest-news/teva-gains-biosimilar-momentum-with-u.s.-fda-approval-of-ponlimsi-denosumab-adet-and-dual-filing-accep

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

. March 5, 2024. Accessed March 31, 2026. 

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Jeremias S. FDA quietly approves denosumab biosimilars, issues interchangeability for others. The Center for Biosimilars. November 13, 2025. Accessed March 31, 2026. 

https://www.centerforbiosimilars.com/view/fda-quietly-approves-denosumab-biosimilars-issues-interchangeability-for-others

Articles

The FDA approved Teva’s biosimilar for denosumab, and the FDA and EMA accepted its asthma biosimilar application for review.

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis

Filkri (filgrastim-laha; Accord BioPharma), a biosimilar to Neupogen (filgrastim; Amgen), was FDA-approved for the treatment of neutropenia, based on 2 randomized studies.

Filkri belongs to the granulocyte colony-stimulating factor (G-CSF) class and is the first short-acting G-CSF biosimilar under Accord Biopharma. G-CSF biosimilars are growth factors manufactured by recombinant DNA technology that regulate the production of neutrophils within bone marrow, a particularly significant treatment for patients undergoing chemotherapy. Neutropenia is common in patients receiving chemotherapy; serious complications can arise during cancer treatments, thus reducing patients’ white blood cell count or neutrophils and increasing the likelihood of patients developing an infection. This addition has expanded Accord BioPharma’s catalog of G-CSF-class biosimilars, which previously included only Udenyca (pegfilgrastim-cbqv; Accord BioPharma)—a long-acting option the company acquired last year. Now with both biosimilars, Accord Biopharma has 6 biosimilars and 7 total products in its portfolio.

FILKRI becomes Accord BioPharma’s first short-acting G-CSF biosimilar, broadening supportive oncology treatment options. | Image Credit: wladimir1804 - stock.adobe.com.jpeg

"With FILKRI alongside UDENYCA, the provider-preferred option over Neulasta and all other biosimilars, we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options,” Chrys Kokino, president of Accord North America, said in a 

. “This positions Accord BioPharma as a committed partner in oncology supportive care, expanding access to high-quality biologics."

Filkri Approval Strengthens Accord’s G-CSF Biosimilar Portfolio in Oncology Supportive Care

Filkri was approved to treat patients with cancer receiving myelosuppressive chemotherapy or undergoing a bone marrow transplant, patients with acute myeloid leukemia (AML) receiving induction or consolidation therapy, patients with severe chronic neutropenia, and patients acutely exposed to myelosuppressive doses of radiation.

The approval was based on results from 2 randomized studies in healthy adults assessing safety and efficacy in both studies and pharmacokinetics/pharmacodynamics in one, compared with Neupogen. The overall findings showed the safety and immunogenicity of Filkri were similar to those of Neupogen.

Patients who received Filkri with nonamyloid malignancies receiving myelosuppressive anti-cancer drugs experienced pyrexia, pain, rash, cough, and dyspnea when compared with the placebo (≥ 5% difference in incidence compared to placebo). Furthermore, patients with AML experienced pain, epistaxis, and rash (≥ 2% difference in incidence). Patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT experienced rash (≥ 5% difference in incidence); and lastly, patients with severe chronic neutropenia experienced pain, anemia, epistaxis, diarrhea, hypoesthesia, and alopecia (≥ 5% difference in incidence).

Biosimilar Growth in the US Continues to Expand Access and Affordability Across Cancer Care

Filkri may be the first short-acting G-CSF for Accord BioPharma; filgrastim is the 

 to ever have an FDA-approved biosimilar. In 2015, 

 (Zarxio; Sandoz) was approved, paving the way for more than 67 biosimilars across 18 originators in the United States.

 Although filgrastim-sndz is a European biosimilar and is approved for hematopoietic stem and progenitor cell mobilization, its presence in the biosimilar space has made a significant impact.

As pharmaceutical companies continue to realize the value of biosimilars for patients and health care systems, they are expanding access and affordability throughout the oncology, rheumatology, immunology, and supportive care spaces.

“This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology,” Binish Chudgar, chairman and managing director of Intas Pharmaceuticals, said in a press release.

 “We're proud to have one of the largest biosimilar pipelines within the industry. With Accord BioPharma, we're positioning ourselves as a dependable partner in the United States—one that's deeply committed to understanding stakeholder priorities and revolutionizing patient access.”

1. FDA approves FILKRITM (Filgrastim-Laha), Accord BioPharma’s biosimilar to NEUPOGEN (filgrastim). News release. PR Newswire. February 17, 2026. Accessed February 18, 2026. 

https://www.prnewswire.com/news-releases/fda-approves-filkri-filgrastim-laha-accord-biopharmas-biosimilar-to-neupogen-filgrastim-302689073.html

2. Jeremias S. Ten years of data support safety of biosimilar filgrastim for donor mobilization. Center for Biosimilars. August 22, 2025. Accessed February 18, 2026. 

https://www.centerforbiosimilars.com/view/ten-years-of-data-support-safety-of-biosimilar-filgrastim-for-donor-mobilization

3. Jeremias S. From Amjevita to Zarxio: a decade of US biosimilar approvals. Center for Biosimilars. March 6, 2025. Accessed February 18, 2026. 

https://www.centerforbiosimilars.com/view/from-amjevita-to-zarxio-a-decade-of-us-biosimilar-approvals

FDA approval of Filkri expands Accord’s G-CSF biosimilar portfolio, offering a short-acting option for neutropenia in cancer care.

FDA Approves Filkri, Accord BioPharma’s Short-Acting Filgrastim Biosimilar for Neutropenia

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.

Mayo Clinic’s Chelsee Jensen, PharmD, shares how FDA guidance, pricing pressures, and formulary strategy are shaping the next wave of biosimilars.

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.

Sabrina McCrear

FDA Approves Teva Biosimilar for Denosumab in Osteoporosis

FDA Approves Filkri, Accord BioPharma’s Short-Acting Filgrastim Biosimilar for Neutropenia

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