Giuliana Grossi

Patients with moderate-to-severe plaque psoriasis who were switched from reference ustekinumab to a first biosimilar and then to a second maintained durable disease control with no serious adverse events.

Patients with moderate-to-severe plaque psoriasis who were switched from reference ustekinumab to a first biosimilar and then to a second maintained durable disease control with no serious adverse events, according to real-world data presented at the 

The study, an ambispective cohort analysis from the University of Lübeck in Germany, followed 39 patients across 4 time points, from initial biologic induction through 2 sequential biosimilar transitions. As health systems move toward biosimilar-first prescribing, investigators aimed to assess if patients could be switched multiple times without losing the clinical ground gained on the originator.

Patients were initially treated with reference ustekinumab (T1), then transitioned to a first biosimilar (Biosimilar A; T2) and subsequently to a second biosimilar (Biosimilar B; T3–T4). Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index and body surface area were assessed at each time point. Laboratory markers and adverse events were also reviewed throughout. Statistical comparisons used Wilcoxon signed-rank tests for paired data.

The cohort had a mean age of approximately 44 years; two-thirds were male, and just over a quarter carried a concurrent diagnosis of psoriatic arthritis. The majority had prior systemic therapy experience, most commonly methotrexate, fumaric acid esters, and phototherapy, underscoring a population with established, often refractory disease.

Reference ustekinumab induction produced a striking reduction in PASI, from a mean of 11.3 at baseline to 1.2 after induction, a change that was highly statistically significant. Crucially, PASI remained essentially flat across both subsequent biosimilar transitions. The small numerical increase observed at T4 (mean 1.6 vs 1.2 at T3) was statistically significant in a paired test, but investigators noted that absolute values remained clinically low throughout, with a median PASI at or near 0.6 from T2 onward.

No serious adverse events were identified during the biosimilar phases. Mild-to-moderate infections were the most commonly recorded clinical events, occurring in 7 patients between T2 and T3, and 4 patients between T3 and T4. Minor psoriasis worsening—defined as PASI below 5—was noted in 2 patients at each of the final 2 intervals; of these, one required dose escalation from 45 mg to 90 mg, and one was eventually switched to tildrakizumab 200 mg. One patient developed enthesitis that resolved with physiotherapy alone. A lentigo maligna was detected and surgically removed in one patient between T3 and T4; this lesion had been identified and monitored before the biosimilar transition began.

Laboratory monitoring showed stability across all measured parameters from T2 through T4. Liver enzyme (ALT/GPT) levels declined significantly between T1 and T2, then held steady. The neutrophil-to-lymphocyte ratio, a proxy for systemic inflammatory activity, fell significantly from T1 to T3 and remained stable thereafter, suggesting that the anti-inflammatory effect of ustekinumab was preserved across both switches.

The findings directly address a practical question facing dermatologists and payers alike: whether health systems can carry out nonmedical switching across multiple biosimilar generations without jeopardizing patient outcomes. The data presented here suggest the answer is yes, at least in the medium term and within this cohort.

Investigators were careful to acknowledge limitations. The ambispective design—retrospective through the first switch, prospective thereafter—introduces potential for selection bias. The sample of 39 patients limits statistical power, and the absence of a concurrent control group means confounders cannot be fully excluded. Follow-up after the second switch was also limited; longer-term durability data would strengthen the case further.

Nonetheless, the authors concluded that sequential switching between ustekinumab biosimilars appears to be a viable, cost-effective strategy that does not compromise efficacy or safety. As biosimilar pipelines for IL-12/23 blockade continue to expand, these real-world data add important evidence to complement the controlled trial literature on individual switches.

1. De Luca DA, Papara C, Pommerien L, Hawro T, Thaçi D. Sequential switching between ustekinumab biosimilars in psoriasis: real-world evidence of clinical interchangeability. Presented at the American Academy of Dermatology Annual Meeting; Poster 72304.

Articles

Real-world study shows plaque psoriasis stays controlled after 2 ustekinumab biosimilar switches, with stable labs and no serious adverse events.

No Efficacy Loss After Multiple Ustekinumab Biosimilar Switches in Psoriasis

From corporate restructuring to pipeline setbacks and surging market penetration in Asia, recent developments across the biosimilar landscape reflect an industry simultaneously navigating opportunity and regulatory complexity.

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom. | Image credit: Planetz - stock.adobe.com

Sandoz Creates Unified Biosimilar Unit, Appoints New President

In a major organizational overhaul aimed at capitalizing on what company leaders described as a "golden decade" of opportunity, Sandoz Group AG announced the creation of a dedicated global biosimilar development, manufacturing, and supply unit, according to a press release published on the Sandoz website.

The company appointed industry veteran Armin Metzger as president of the new division and member of the executive committee. Metzger, who previously held senior roles at Ferring and Merck, is scheduled to officially join the Executive Committee on April 1, 2026.

The initiative was designed to capitalize on anticipated opportunities arising from the upcoming expirations of medical exclusivity, valued at more than USD 650 billion over the next decade. By consolidating all biosimilar activities, such as spanning development, manufacturing, and supply chain under a single executive, Sandoz is hoping to speed decision-making, deepen vertical integration, and tailor strategies to distinct market dynamics.

Concurrent leadership changes included the appointment of Claire D'Abreu-Hayling as president of generics development and Glenn Gerecke as president of generics manufacturing and supply, effectively separating the generics and biosimilars businesses under specialized leadership. Sandoz posted full-year 2025 revenue of $11.09 billion, with biosimilar sales growing 13% at constant currency to $3.29 billion, representing 30% of total revenue, underscoring why the company moved to sharpen its structural focus on the segment.

Outlook Therapeutics Evaluates Options After FDA Type A Meeting on Bevacizumab Candidate

In contrast to Sandoz's forward momentum, Outlook Therapeutics stated that it was still weighing its regulatory options for its bevacizumab ophthalmic candidate following a Type A meeting with the FDA, as reported by Pearce IP.

The Type A meeting was held to clarify the outstanding issue identified in the complete response letter (CRL), issued December 30, 2025, regarding substantial evidence of effectiveness for ONS-5010/LYTENAVA (bevacizumab-vikg)—and to discuss potential paths forward for regulatory approval. The biologics license application (BLA) had been submitted for the treatment of wet age-related macular degeneration (wet AMD).

Outlook Therapeutics stated it was evaluating available regulatory options to advance ONS-5010/LYTENAVA toward potential US approval, noting that the product demonstrated clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO randomized, double-masked, active-controlled phase 3 trial, which met its primary and key secondary end points.

The company noted that if approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. The product has already received marketing authorization in Europe and was commercially launched in Germany, Austria, and the United Kingdom for wet AMD treatment, providing some commercial foundation as the company navigated the US regulatory path.

Celltrion Biosimilars Achieve Dominant Shares Across Asian Markets

While others grappled with structural or regulatory challenges, Korean biopharmaceutical company Celltrion reported strong commercial gains across Southeast Asia and other key Asian markets, according to Korea BioMedical Review.

The company said it drove prescription growth in Malaysia, Singapore, Thailand, and Hong Kong through tender wins and localized sales strategies, with several key product lines achieving leading market shares.

Celltrion's flagship infliximab biosimilar, Remsima, held market shares of 93% in Singapore, 77% in Hong Kong, 73% in Thailand, and 65% in Malaysia as of the third quarter of 2025, according to IQVIA, a pharmaceutical market research firm. 

Performance extended beyond autoimmune disease. Herzuma (trastuzumab), a treatment for people with breast and gastric cancer, held prescription shares of 87% in Thailand, 57% in Hong Kong, and 51% in Malaysia as of Q3 2025, while Truxima (rituximab), a treatment for people with blood cancers, maintained leading prescription shares of 90% in Singapore and 79% in Thailand. 

Celltrion's adalimumab biosimilar, Yuflyma, was also gaining ground, surpassing its originator product to become the second-most prescribed treatment for people with autoimmune conditions in Singapore. Looking ahead, Celltrion's Thai subsidiary announced plans to launch 3 new biosimilars in 2026—ustekinumab, bevacizumab, and omalizumab—to build on its existing portfolio of 5 marketed products in the country.

Sandoz Group AG. Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth. Published March 10, 2026. Accessed March 10, 2026. 

https://www.sandoz.com/sandoz-creates-new-global-biosimilar-development-manufacturing-and-supply-unit-appoints-industry

Pearce IP. Outlook Therapeutics provides update regarding bevacizumab biosimilar after Type A FDA meeting. Published March 5, 2026. Accessed March 10, 2026. 

https://www.pearceip.law/2026/03/05/outlook-therapeutics-provides-update-regarding-bevacizumab-biosimilar-after-type-a-fda-meeting/

Lee H. Celltrion biosimilars secure leading share in key Asian countries. 

. Published March 9, 2026. Accessed March 10, 2026. 

https://www.koreabiomed.com/news/articleView.html?idxno=30850

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

The global biosimilar landscape continues to evolve as European regulators expand treatment options for patients with chronic conditions, while legal battles in the US highlight the ongoing tension between biosimilar manufacturers and originator companies over market entry.

European Regulators Recommend Approval for Fifth Teriparatide Biosimilar

On February 26, 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending that a marketing authorization be granted for Zandoriah.

 Developed by CinnaGen, Zandoriah was designed as a biosimilar to the reference product Forsteo (teriparatide), which was produced by Eli Lilly.

Teriparatide is a recombinant form of parathyroid hormone (PTH). This agent serves as an anabolic, or bone-growing, treatment that activates osteoblasts to increase bone formation. The CHMP recommended Zandoriah for the treatment of postmenopausal women and men with osteoporosis who were at a high risk of fracture. Additionally, the recommendation covered patients with osteoporosis associated with sustained systemic glucocorticoid therapy.

Clinical data submitted to the committee demonstrated that Zandoriah possessed comparable quality, safety, and efficacy to its reference product. If the European Commission (EC) follows the recommendation, Zandoriah will become the fifth teriparatide biosimilar authorized in the European Union (EU), joining previously approved options such as Sondelbay and Terrosa. This marks the first biosimilar from CinnaGen to receive a positive CHMP opinion for the European market.

European Commission Grants Marketing Authorization for Gotenfia

Shortly before the recommendation for Zandoriah, the EC granted marketing authorization for Gotenfia (golimumab) on February 13, 2026.

 This biosimilar, which references Simponi, was developed through a partnership between Bio-Thera Solutions and STADA Arzneimittel AG. Gotenfia was approved for the treatment of patients with several chronic inflammatory autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

Gotenfia functions as a human monoclonal antibody that targets tumor necrosis factor alpha, a pro-inflammatory molecule. The authorization applied across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. As the second golimumab biosimilar approved in the EU, Gotenfia was expected to increase market competition and lower unit costs for biological treatments.

STADA, which held exclusive commercialization rights in the EU and UK, noted that this was its 11th biosimilar authorization. Bio-Thera remained responsible for the development and manufacturing of the product. Launch preparations were reported to be underway to bring this once-monthly treatment option to healthcare providers and their patients in the coming months.

Genentech Initiates Patent Litigation Against Biocon Over Pertuzumab

While European markets expanded, the US saw new legal hurdles for biosimilar entry. On February 27, 2026, Genentech filed a formal complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of a pertuzumab biosimilar, BMAB 1500, violated Section 337 of the Tariff Act. Biocon’s biologics license application (BLA) referenced Perjeta (pertuzumab), a therapy used for patients with HER2-positive breast cancer.

Genentech contended that Biocon imported more than 17,800 pieces of the biosimilar from India in October 2025. The complaint characterized this activity as "stockpiling" commercial supplies before receiving approval from the FDA. Genentech argued that such conduct fell outside the patent infringement "safe harbor," which typically protects importation solely for the development of information for federal regulatory review.

The litigation involved 4 asserted patents covering the pharmaceutical compositions and manufacturing methods of the antibody. Genentech sought a limited exclusion order to block the importation of the product until the patents expired, with the latest expiration date set for September 2031. Unlike district court litigations, ITC investigations generally reach a final decision within 16 months and focus on excluding infringing products from the border rather than awarding monetary damages. This legal action followed a similar case involving another pertuzumab biosimilar, Poherdy, which was approved by the FDA in November 2025 and settled in early 2026. 

Generics and Biosimilars Initiative. EMA recommends approval for teriparatide biosimilar Zandoriah. Generics and Biosimilars Association. Published March 4, 2026. Accessed March 5, 2026. 

https://gabionline.net/biosimilars/news/ema-recommends-approval-for-teriparatide-biosimilar-zandoriah

Bio-Thera Solutions, Ltd., STADA, and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi. Bio-Thera Solutions. News release. Published February 13, 2026. Accessed March 5, 2026. 

https://www.prnewswire.com/news-releases/stada-and-bio-thera-receive-european-marketing-authorization-for-gotenfia-a-biosimilar-to-simponi-302687571.html

Nock J, Wang S. ITC as a Biosimilar Battleground: Genentech Challenges Biocon's Pertuzumab Biosimilar. JD Supra. Published March 5, 2026. Accessed March 5, 2026. 

https://www.jdsupra.com/legalnews/itc-as-a-biosimilar-battleground-1228151/

CHMP backs a fifth teriparatide biosimilar as biosimilars in Europe grow, while US patent fights threaten new biologic competition.

Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles

For people with advanced hepatocellular carcinoma whose disease has progressed despite prior immunotherapy, treatment options have remained limited and largely empirical. New findings from the 

suggested that integrating stereotactic body radiotherapy (SBRT) with continued immune checkpoint inhibition and a bevacizumab biosimilar may offer a strategy to overcome resistance while maintaining an acceptable safety profile.

A phase 2 trial found that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar generated meaningful responses in people with advanced liver cancer whose disease had progressed on prior immunotherapy. | Image credit: natali_mis - stock.adobe.com

The open-label, single-arm ReUNION-1 study, published in Nature Communications, evaluated SBRT followed by sintilimab (a PD-1 inhibitor) plus a bevacizumab biosimilar in people with unresectable hepatocellular carcinoma (HCC) whose disease had progressed after at least one prior anti–PD-1–based regimen. Immune checkpoint inhibitor resistance remains a substantial challenge in HCC, where objective response rates to monotherapy have historically ranged from 13% to 20%, and where second-line standards have largely been extrapolated from sorafenib-pretreated populations.

Between March 2022 and April 2024, investigators screened 25 patients and enrolled 21. All participants were included in the intention-to-treat analysis. The median age was 55 years, and 81.0% were men. All patients had Child-Pugh class A liver function and an Eastern Cooperative Oncology Group performance status of 0 or 1. Chronic hepatitis B virus infection was the predominant underlying liver disease (85.7%). Most patients (61.9%) had received one prior line of systemic therapy, and 71.5% had extrahepatic metastases. Nearly all had previously received a tyrosine kinase inhibitor plus a PD-1 inhibitor combination.

Patients underwent SBRT (median dose 8 Gy per fraction for 5 fractions) directed at a selected lesion, followed by sintilimab 200 mg and bevacizumab biosimilar 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) in nonirradiated lesions per RECIST v1.1 criteria.

At a median follow-up of 9.1 months, the ORR in nonirradiated lesions was 33.3%, with 7 of 21 patients achieving a confirmed partial response. Stable disease was observed in 7 additional patients, resulting in a disease control rate (DCR) of 66.7%. Notably, irradiated lesions demonstrated a 100% local-regional control rate, and 76.2% achieved an objective response within the treated field. Durable disease control lasting at least 6 months was observed among patients with partial response or prolonged stable disease.

Median progression-free survival (PFS) was 6.2 months (95% CI, 3.7-15.1), with 6- and 12-month PFS rates of 57.1% and 14.3%, respectively. The estimated median overall survival (OS) was 24.4 months (95% CI, 9.2 months–not reached). Eight deaths had occurred at data cutoff.

Treatment-related adverse events (TRAEs) of any grade occurred in 81.0% of patients. Grade 3 or higher TRAEs were reported in 33.3%, including decreased platelet count, neutropenia, and gastrointestinal hemorrhage. Two grade 4 gastrointestinal hemorrhages were managed with endoscopic intervention, and 1 patient experienced grade 3 anaphylaxis requiring discontinuation of sintilimab. No treatment-related deaths were reported, and 14.3% discontinued therapy due to serious TRAEs.

The study also incorporated serial proteomic and immune profiling analyses. Responders had lower baseline interferon-γ (IFN-γ) levels and higher IL-6 and TNF-α levels compared with nonresponders. Lower baseline IFN-γ levels were associated with longer PFS and OS; patients with low IFN-γ had a median OS of 24.4 months compared with 9.3 months in those with high IFN-γ (HR, 4.12; 95% CI, 1.36-12.46). SBRT was associated with increased circulating IL-6, IL-15, and CD70 levels and decreased VEGFA levels, suggesting immune modulation that may have contributed to renewed sensitivity to PD-1 blockade.

The investigators acknowledged several limitations, including the small sample size, single-arm design, and enrollment at a limited number of centers in China, where hepatitis B–related HCC predominates. The relatively short follow-up period and lack of a comparator arm limited definitive conclusions regarding survival benefit. In addition, prior treatment heterogeneity may have influenced outcomes.

For managed care stakeholders monitoring the evolving biosimilar landscape, the use of a bevacizumab biosimilar in combination with immunotherapy and radiotherapy demonstrated feasibility in a heavily pretreated population. Although confirmatory randomized trials are needed, the findings suggested that combining locoregional and systemic approaches may represent a viable strategy for people with HCC whose disease has progressed on prior PD-1–based therapy.

1. Tang J, Yang Y, Liu D, et al. Stereotactic body radiotherapy with sintilimab and bevacizumab biosimilar in anti-PD-1 refractory hepatocellular carcinoma: the ReUNION-1 phase 2 trial. 

. 2025;17(1):823. doi:10.1038/s41467-025-67528-4

2. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. 

. 2022;1(8):EVIDoa2100070. doi:10.1056/EVIDoa2100070

3. Qin S, Kudo M, Meyer T, et al. Tislelizumab vs Sorafenib as first-line treatment for unresectable hepatocellular carcinoma: a phase 3 randomized clinical trial. 

. 2023;9(12):1651-1659. doi:10.1001/jamaoncol.2023.4003

A phase 2 trial showed that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar can elicit responses in advanced liver cancer.

Biosimilar-Backed Triplet Regimen Shows Feasibility in Heavily Pretreated Liver Cancer

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

The gastroenterology biosimilar landscape is undergoing rapid transformation, dominated primarily by the introduction of ustekinumab biosimilars (referencing Stelara) and the ongoing dynamics of the adalimumab biosimilar market (referencing Humira). The following roundup highlights the top 5 news stories detailing these developments, focusing on regulatory milestones, market challenges, and real-world clinical outcomes for inflammatory bowel disease (IBD) and related gastrointestinal conditions.

5. High Acceptance Levels After Switching to an Adalimumab Biosimilar for IBD

Positive real-world data emerged regarding patient willingness and clinical outcomes following a switch to an adalimumab biosimilar. A French observational study focused on patients with IBD, which includes Crohn disease and ulcerative colitis, who were offered a switch from the reference adalimumab product. The study found "high acceptance levels" among patients with IBD who received education and personalized guidance regarding the switch.

Specifically, 92% of patients accepted the switch, and a notable 71% remained on a biosimilar after 12 months. Clinical outcomes were strong: 85% of switched patients remained in clinical remission at the 12-month mark, suggesting that the switch had no negative impact on disease control. The high cost of biologics, including adalimumab, makes these biosimilar alternatives crucial for treating the estimated 7 million people with IBD around the world.

While the majority reported a positive experience (66%), the most frequent reason for discontinuing the biosimilar was injection site pain (25%). Researchers concluded that most patients with IBD were receptive to switching to a biosimilar and achieved good outcomes, emphasizing that continuous patient education and addressing individual concerns are "crucial for improving overall satisfaction with biosimilars."

4. FDA Approves Starjemza as New Stelara Biosimilar

The momentum in the ustekinumab space continued with the FDA approval of Starjemza (ustekinumab-hmny) in May 2025, marking the eighth ustekinumab biosimilar to receive regulatory clearance. Starjemza, developed through a partnership between Hikma Pharmaceuticals and Bio-Thera Solutions, is approved for treating several rheumatic and gastrointestinal conditions.

The approval further enhances the treatment landscape for patients, following the approval of Steqeyma in late 2024. The FDA’s decision was based on data from 2 clinical studies, including a phase 3 trial in patients with moderate to severe plaque psoriasis, which confirmed that Starjemza maintained comparable efficacy, safety, and immunogenicity to the reference product, Stelara. At the time of this approval, 6 ustekinumab biosimilars were already available on the US market, some of which—like Wezlana—are available exclusively through private label distributors.

3. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

In a significant market shift concerning biologics used to treat conditions like Crohn disease and ulcerative colitis, AbbVie’s Skyrizi (risankizumab-rzaa) officially surpassed Humira (reference adalimumab) as the company’s leading sales driver in the third quarter of 2024. The change can be attributed to the practice of "product hopping," where originator companies strategically shift patient demand from an innovator drug facing biosimilar competition (Humira) to a newer, patented product (Skyrizi or Rinvoq) that treats the same indications.

This market maneuver has complicated the sustainability of the US adalimumab biosimilar space. While 10 adalimumab biosimilars have launched since January 2023, the combined market shares only reached 22% by October 2024, a notable improvement from the 2% share after the first year. However, the growth of Skyrizi and Rinvoq has led to a "large drop in total adalimumab volume," effectively shrinking the overall market size, meaning biosimilars are gaining share in a diminishing pie.

Experts attending the GRx+Biosims conference emphasized that policy reforms, such as fair access fees and better formulary placement, are necessary to ensure a transparent and competitive market for biosimilars to thrive against product hopping practices.

2. 3 Ustekinumab Biosimilars Launch on US Market

The ustekinumab market heated up quickly following Wezlana's launch, as 3 additional biosimilars entered the US market in February 2025. These competitors—Pyzchiva (ustekinumab-ttwe) from Samsung Bioepis/Sandoz, Yesintek (ustekinumab-kfce) from Biocon Biologics, and Selarsdi (ustekinumab-aekn) from Teva/Alvotech—expand patient access to more affordable options referencing the blockbuster drug Stelara. Stelara generated $10.4 billion in sales in 2024 alone.

All 7 FDA-approved ustekinumab biosimilars are indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Inflammatory bowel disease, encompassing Crohn disease and ulcerative colitis, is estimated to impact between 2.4 million and 3.1 million Americans. The Crohn's and Colitis Foundation's chief education, support, and advocacy officer commented that this influx of options represents a "meaningful advancement" for eligible patients with chronic disease. The competition is particularly important because Wezlana's initial access is restricted by its exclusive agreement with Nuvaila. Although Pyzchiva has been provisionally designated as interchangeable, it must wait for the lapse of Wezlana's one-year exclusivity for being the first interchangeable ustekinumab biosimilar before the full designation can be granted.

1. Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

January 1, 2025, marked a significant moment for gastroenterology patients with the launch of the first ustekinumab biosimilar in the US: Amgen’s Wezlana (ustekinumab-auub). Ustekinumab products, which are interleukin (IL)-12 and IL-23 antagonists, are crucial for treating conditions like Crohn disease and ulcerative colitis, in addition to plaque psoriasis and psoriatic arthritis. The arrival of Wezlana, delayed from a projected 2023 launch due to a settlement with Johnson & Johnson, ushers in a new class of lower-cost biologics for Americans with these gastrointestinal and rheumatic conditions.

Wezlana was the first ustekinumab biosimilar to receive FDA approval and possesses an interchangeability designation. This designation is key for patient access and convenience, as it allows the biosimilar to be substituted for the reference product, Stelara, at the pharmacy level without requiring prior provider approval. However, the initial launch has been partially limited: the biosimilar is exclusively available through Nuvaila, Optum Rx's biosimilar procurement business. This launch is being closely watched to see if it follows the path of adalimumab biosimilars, especially concerning the risk of "product hopping," where the originator company might shift patients to a newer product, such as Tremfya (gusekumab), to limit the uptake of biosimilars. Wezlana’s approval was supported by a phase 3 trial confirming comparable safety and efficacy profiles to Stelara.

Explore this year's advancements in gastroenterology biosimilars, highlighting key FDA approvals and market dynamics impacting IBD treatment options.

Giuliana Grossi

No Efficacy Loss After Multiple Ustekinumab Biosimilar Switches in Psoriasis

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles

Biosimilar-Backed Triplet Regimen Shows Feasibility in Heavily Pretreated Liver Cancer

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

Top 5 Most-Read Gastroenterology Articles of 2025

Top 5 Most-Read Regulatory Articles of 2025

Denosumab, Golimumab Biosimilars Clear Major Regulatory Milestones in Europe, as US Hurdles Remain