Podcasts

Ping Cao, vice president of Business Development for Shanghai Henlius Biotech, discussed the company's current biosimilar development plans and the process for getting regulatory approval for biosimilars in China.

Not So Different: How Henlius is Making Its Mark on the Global Biosimilar Industry

Sophia Z. Humphreys, PharmD, MHA, is the director of System Pharmacy Clinical Services for Providence St. Joseph Health (PSJH), a multistate hospital system based in Renton, Washington. She has nearly 20 years of specialized experience in the pharmaceutical industry and is an expert in pharmacy regulatory compliance, US Pharmacopeia General Chapter <797>/<800> pharmacy regulations, clinical education, long-term care pharmacy service, and pharmaceutical waste management. She has a strong background in strategic planning and project management. Prior to her current position, she served as the PSJH drug information manager.

Articles

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–.  - related financial wreckage behind them.

Opinion: Biosimilars Can Aid in Post–COVID-19 Health Care Financial Recovery

Tony Hagen is senior managing editor for The Center for Biosimilars

Amneal Pharmaceuticals develops its biosimilar pipeline with mAbxience, Xcenda estimates biosimilar effect on originator pricing, and Magellan Rx Management touts oncology biosimilars savings.

News Roundup: Amneal's Bevacizumab Biosimilar, Originator Pricing Impact, and More

Getting to the stage where clinical data on interchangeability are reportable to the FDA is a key milestone in Alvotech’s bid to get its high-concentration adalimumab biosimilar approved and on the market. 

Alvotech Achieves Milestone in Bid to Capture Adalimumab Share

Videos

Here are the top 5 biosimilar articles for the week of June 14, 2021.

The Top 5 Biosimilar Articles for the Week of June 14

, 3 experts assess the state of the biosimilars industry in India and some of the biggest issues facing its success.

Sarfaraz K. Niazi, PhD, an adjunct professor of biopharmaceutical sciences at the University of Illinois, Chicago, contends that India’s guidelines involve requirements for unnecessary nonclinical data, such as from animal trials, and do not contain acceptable requirements for the number of patients needed to conduct a clinical study.

Anurag Rathore, PhD, a professor in the Department of Chemical Engineering at the Indian Institute of Technology in Delhi, India, states that a lot of India’s biologics issues aren’t necessarily with the guidelines, but are with guideline adherence, in that most regulators have specialized in small molecule drugs and have limited experience working with biologics.

Paul Cornes, BM, BCH, MA, MRCP, FRCR, a consultant oncologist and biosimilars expert who was part of the team that developed and presented evidence to the FDA for the first successfully approved US biosimilar, explains why reducing biosimilar development costs without sacrificing clinically relevant data is important, including that most patients with cancer are from low- and middle-income countries, where affordable drugs are needed.

Rathore notes that India has tremendous skill already with producing safe and effective drugs because roughly half of the products on the US market are manufactured in India despite challenges. He agrees that it’s critical for India to manufacture biologics economically to improve affordability, but that it’s also important to improve the reliability of data coming from clinical trials.

Cornes states that India does have the resources to produce world class biosimilars but that he has concerns over whether there are too many small players and too much competition in the Indian marketplace, such that the large companies with the quality and resources to compete globally may find it hard to get the recognition they deserve. 

Niazi states that the standards put forth by the Central Drugs Standard Control Organization (CDSCO) are not optimal to allow for trial data to be accepted worldwide, which results in a lot of Indian companies doing only what is needed to receive approval in India. This means that none of the locally produced biosimilars sold exclusively in India could qualify for use in Western countries without companies having to redo their trials from scratch.

In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally. 

Part 1: Panelists Suggest More Groundwork Is Needed for Indian Biologics to Achieve Global Market Access

Guangzhou, China–based Bio-Thera Solutions has 

 for its golimumab biosimilar candidate (BAT2506) referencing Simponi.

The double-blind, randomized, parallel, control study will compare the efficacy and safety of BAT2506 with the reference product in patients with psoriatic arthritis (PsA). An estimated 480 patients will be enrolled.

In the United States, Simponi is indicated for PsA, with or without methotrexate, and in moderate to severe rheumatoid arthritis in combination with methotrexate for ankylosing spondylitis and moderate to severe ulcerative colitis.

“Bio-Thera is focused on developing and commercializing a pipeline of safe, effective, and affordable biosimilars and is proud to be a step closer to bringing a Simponi biosimilar to patients around the world,” said Shengfeng Li, CEO.

In January 2021, Bio-Thera had the biologics license application (BLA) for a bevacizumab biosimilar, BAT1706, 

 by the FDA, and regulators in China accepted the 

The company is seeking to offer the bevacizumab product for use in all indications of Genentech’s reference agent (Avastin), including advanced, metastatic, or relapsed non–small cell lung cancer and metastatic colorectal cancer.

The company is also developing biosimilar forms of the tocilizumab and ustekinumab immunosuppressants, along with mepolizumab (asthma, inflammation) and dupilumab (allergies, including eczema and asthma) biosimilars.

In April 2021, Bio-Thera said it had signed an agreement with Biogen for the commercialization of the tocilizumab biosimilar (BAT1806). The drug is an anti–interleukin-6 receptor monoclonal antibody that references Actemra and would be targeted for treatment of moderate to severe rheumatoid arthritis in adults, juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and cytokine release syndrome.

BAT1806 met safety and efficacy end points in a recent 

 to BAT1806 in all countries outside the China area.

Bio-Thera has set up a psoriatic arthritis clinical trial for BAT2506, which references Simponi. 

 Bio-Thera Moves Golimumab Candidate Into Phase 3 Trial

Lack of confidence in biosimilars among health care practitioners

Nocebo/failure to properly educate patients about biosimilars

Differences between biosimilars and originator agents

Lack of clear policy on managing patients with negative outcomes

Reverse switching is a concern for health care centers that are attempting to introduce value-based care. Studies have shown that strong patient and staff education efforts can reduce reverse switching and improve outcomes with biosimilars. In addition, investigators have reported that 

can strongly influence patient willingness to use biosimilars and persist in treatment. It has also been reported that physicians may revert to originators because their health care centers 

 on management of adverse reactions. The 

 has been identified as a major reason for reverse switching. 

Reverse switching occurs when patients transitioned to or initiated on a biosimilar are changed to an originator product, often because of a perceived failure in the biosimilar therapy.

Poll: Identify the Main Cause for Reverse Switching

The Oncology Care Model (OCM), begun in 2016 by CMS to promote value-based care over costly “buy and bill” pharmacy practices, has “led to reduced use of some high-cost supportive care medications, with patterns suggesting more value-conscious care,” according to findings presented at ASCO 2021.

Alternative payment models have potential to drive value-based changes in medication use during cancer care.

Investigators sourced Medicare claims from 2013 to 2019 in an evaluation of outpatient supportive care medication use during chemotherapy treatment at practices participating in the OCM or in “propensity-matched comparison practices,” used as an artificial cohort.

Except for a filgrastim biosimilar analysis, where the adoption trend was assessed, the investigators used a differences-in-differences (DID) statistical method to compare findings between cohorts.

The OCM had no effect on the use of any type of bone supportive medication (denosumab or bisphosphonate) among patients with metastasized bone cancer; however, it did result in lower use of denosumab in patients with breast cancer (DID = –5.0 percentage points; 90% CI, –7.1 to –2.8), prostate cancer (DID = –4.0 percentage points; 90% CI, –5.9 to –2.2), and lung cancer (DID = –4.1 percentage points; 90% CI, –7.4 to –0.9).

The OCM resulted in lower use of neurokinin-1 (NK1) antagonists and serotonin antagonists in patients who were starting chemotherapy with high or moderate emetic risk, according to the authors. This included a 6-percentage-point reduction in use of NK1 antagonists for patients undergoing high–emetic risk chemotherapy (90% CI, –9.0 to –3.1), as opposed to no effect on antiemetic use during low–emetic risk chemotherapy.

No change was noted in use of prophylactic white blood cell growth factors among patients receiving chemotherapy with high risk for febrile neutropenia (FN).

A 7.6-percentage-point reduction in prophylactic granulocyte colony stimulating factor (G-CSF) was observed for patients with breast cancer receiving chemotherapy with intermediate risk for FN (90% CI, –12.6 to –2.7). Conversely, no change in prophylactic G-CSF use was observed for patients with lung or colorectal cancer.

The OCM resulted in faster adoption of filgrastim biosimilar vs originator product for patients treated with this agent (differential trend estimate, 2.6%; 90% CI, 1.0%-4.4%).

“Alternative payment models have potential to drive value-based changes in medication use during cancer care,” the authors concluded.

Brooks GA, Landrum MB, Kapadia NS, et al. Impact of the Oncology Care Model on use of bone supportive medications, antiemetics, and growth factors. Presented at: ASCO 2021: June 3-7, 2021. Abstract 1517. 

Investigators noted a reduction in use of high-cost supportive care agents, suggesting that the value-based Oncology Care Model (OCM) is working. 

Study: OCM Reduces Use of Some Supportive Care Medications and Boosts Filgrastim Biosimilar Use

Investigators in Alberta, Canada, said no significant differences in pathologic complete response rates (pCRs) were observed in a study of patients with human epidermal growth factor receptor 2–positive (HER2+) treated with the biosimilar trastuzumab Ogivri vs the originator product, Herceptin.

pCR rates were similar for patients treated with [Ogivri] compared with [Herceptin] in our real-world study of HER2+ neoadjuvant [early breast cancer] and comparable to pivotal phase 3 trials.

The study authors postulated that although biosimilars are certified as having no clinically meaningful differences from originator products, there is potential for clinically meaningful differences in outcomes because biosimilar manufacturers must produce new cell lines to replicate originator biologics and are not given access to the originator cell lines.

Concerns about “this inherent alteration in production” are settled through phase 1 pharmacokinetic and pharmacodynamic comparative studies and phase 3 studies to demonstrate biosimilar equivalency in patients for at least 1 indication of the originator product, investigators said.

Prior confirmatory studies have evaluated the biosimilarity of Ogivri and Herceptin in the metastatic HER2+ setting. In this study, investigators sought to elucidate biosimilar equivalence in the neoadjuvant, or early breast cancer (EBC), setting.

The study enrolled patients (N = 136; 56% originator, 43% biosimilar) treated with trastuzumab originator from November 2018 to October 2019 and the biosimilar from December 2019 to September 2020. There was no crossover between products. Investigators used logistic regression to control for factors that might affect pCR in either cohort, such as biosimilar or originator agent, age, tumor type, node positivity, tumor grade, hormone receptor status, treatment with chemotherapy, and whether chemotherapy treatment was completed.

Based on the logistic regression model, investigators saw no significant difference in pCR odds for patients treated with biosimilar vs originator (odds ratio [OR], 1.1; 95% CI, 0.5-2.4; 

 = .85). However, there was a statistically insignificant lower likelihood of pCR in patients with anthracycline use (OR, 0.72; 95% CI, 0.3-1.6; 

Investigators observed no significant differences in baseline characteristics among patients except the proportion of those with node negative results: 39%, biosimilar; 14.3%, originator (

 = .001). For patients treated with biosimilar vs originator, pCR was a nonstatistically significant 35.6% vs 40.3%, respectively (

“pCR rates were similar for patients treated with [Ogivri] compared with [Herceptin] in our real-world study of HER2+ neoadjuvant EBC and comparable to pivotal phase 3 trials,” the authors concluded.

Yang C, Khwaja R, King K, et al. Trastuzumab-dkst versus trastuzumab: real-world pCR rates in patients with HER2+ breast cancer treated with neoadjuvant chemotherapy plus trastuzumab from Alberta, Canada. Presented at: ASCO 2021; June 3-7, 2021. Abstract e12569.

Investigators further elucidate the equivalence of a trastuzumab biosimilar vs Herceptin in human epidermal growth factor receptor 2–positive (HER2+) breast cancer. 

Ogivri Equivalence Demonstrated in Neoadjuvant HER2+ Comparative Trial

Eleven biosimilars for use in oncology have been launched since the start of 2019, and investigators who sought to measure oncologists’ response to these agents reported initial hesitation, followed by robust uptake and hefty savings.

They noted that the biosimilar competition had little effect on reference product prices, which “remained stable.”

We conclude that uptake of biosimilars among oncology providers between 2019-2020 was rapid, although the extent of biosimilar prescribing varied among products. Biosimilars offered greatly reduced costs to providers, although reference product prices remained stable despite increased biosimilar competition.

The findings were reported in an abstract published at the ASCO 2021 meeting. Investigators drew their data from prescription information published by Wolters Kluwer (n = 130,836), sales data from IQVIA, and dosage information published by ION Solutions.

Investigators found that in 2020, 8.2% of new prescriptions for bevacizumab, rituximab, and trastuzumab were for biosimilar versions. For bevacizumab, there are currently 2 biosimilars available; rituximab, 3; and trastuzumab, 5.

Findings for use of trastuzumab biosimilars revealed a dramatic increase from the first year of availability to the next. In the first 3 months of 2019, 7.3% of initiating first-line patients were prescribed trastuzumab biosimilar vs reference product. In the first quarter of 2020, when all 5 trastuzumab biosimilars had become available, the new prescriptions rate was 80.5% for patients receiving first-line care.

Uptake rates differed for individual biosimilars. The investigators reported that Ruxience, the first available rituximab biosimilar, had initial uptake of just 2.3%.

And further, they did observe willingness among oncologists to switch patients from reference products to biosimilars. They said 11.1% of patients (bevacizumab, 11.3%; trastuzumab, 14.1%; rituximab, 7.9%) were transitioned from the reference biologics to biosimilars during treatment.

“Uptake was particularly rapid for trastuzumab biosimilars,” investigators said. “Among patients on trastuzumab at the time of its first biosimilar launch, 18.2% switched to [the Kanjinti trastuzumab biosimilar] in the first 90 days postlaunch.”

Significant savings were a feature of the use of biosimilars in the oncology practices, the authors said. Costs per biosimilar prescription were lower than the reference product prescription cost by 42.0%, 29.9%, and 89.5% for trastuzumab, rituximab, and bevacizumab, respectively.

“However, biosimilar launches had little impact on reference product pricing, with 2019 to 2020 year-over-year (YOY) differences in price per prescription close to the YOY averages in previous years (2015-2019) for all 3 reference products,” the authors wrote.

McGlynn KA, McGarry J, Patel KB, Clinton N. Real-world trends in biosimilar prescribing among oncology providers, 2019-2021. Presented at: ASCO 2021: June 3-7, 2021. Abstract e18701.

When biosimilars emerged in oncology, oncologists dipped in a toe and then got serious, according to a retrospective study on usage and savings presented at ASCO 2021.

Study Suggests Oncologists' Use of Biosimilars Grew From Trickle to Flood

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

Section 7002 of the Biologics Price Competition and Innovation Act, which details the approval pathway for biosimilar biological products, has come a long way with the issuance of several FDA guidance documents—some revised and 1 withdrawn. Developers and the FDA have collaborated on rewriting recommendations for establishing biosimilarity that will support the Section 7002 mandate to enable faster development of biosimilars, benefiting American patients. This column is abstracted from my citizen petition to the FDA on the same topic.

Although all FDA guidelines include a disclaimer that the guidance provided is suggestive and neither the developer nor the FDA is bound by it, this disclaimer is universally ignored, and the developers try to comply with the listed recommendations. I recommend that the FDA look at the suggestions made here and create a new guideline that will be rational and less demanding on developers without compromising the safety and efficacy of biosimilars.

In submitting my thesis, I am introducing a few new terms. Legacy attributes are the critical quality attributes (CQAs) for which release specifications have been well-established. There is no need to test these attributes side by side with the reference product. Nonlegacy attributes are established based on the testing of the reference product, but not necessarily in a comparative mode. Qualification testing is intended to verify that the active molecule sufficiently matches the reference product, and all of this testing is conducted on a smaller number of batches.

Creating a rational approach requires examining all CQAs based on the relevance and appropriateness of testing. The CQAs are divided into product-related and process-related attributes; the former require comparative testing with the reference product and the latter only if a legacy range of variability cannot be established. This concept is presented in the 

CQAs comprise the properties that can affect the safety and safety of the product. How these attributes are tested should be segregated by product attributes associated with the expression system and process attributes associated with the manufacturing process. The product attributes are the least variable, as they should be, and establish the suitability of the product for further development. These attributes should not be compared with legacy values such as the structure reported in the literature; the comparisons must be made in side-by-side testing with the reference product. Because the product-related attributes have narrow acceptance criteria, only 3 lots of biosimilar candidates and reference products would suffice for testing. Forced degradation studies can be considered as both product and process-related attributes as they tell much about the inter- and intramolecular bindings determined by the primary, secondary, and tertiary structures. Unfortunately, the 

 does not recognize the value of forced degradation or accelerated stability testing in a comparative mode, missing out on a critical method of evaluating molecular structure.

The molecular structure is further confirmed through a biological lens that can comprise in vitro pharmacology, nonclinical pharmacology (pharmacokinetic [PK] studies in animals). Animal PK studies help support structural similarity through the eyes of a biological system to view the molecules, albeit the disposition profiles are different in humans. Although such studies are required for antibody testing in larger species, these should be required for all products.

The most important test is the human PK/pharmacodynamic (PD) study based on how the body sees the molecules and how the molecules see the body. Novel study protocols can combine the PK/PD and immunogenicity testing in a single study that can be made more powerful by narrowing down the inclusion/exclusion criteria, because the purpose of these studies is to compare, not characterize, the profiles. One such type of study can be a 2-periods, parallel, 2-dose study.

Although the expression system determines the product's structure, the rest of the variations result from differences and variabilities in the process, from upstream to downstream to the formulation. These CQAs cannot be 1-time testing and should be included in the release specifications. The CQAs can be classified into 2 categories: 1 where the release limits are well-known and well-established, and the other where the limits must be established based on the ranges obtained from the reference product. This concept of similarity establishment is efficient and based on scientific principles, and it reduces the burden of testing substantially (

Animal toxicology studies are not needed, because the molecule's safety has been established, and any minor differences in the structure or posttranslational modificationprofile will not be detected because the testing is conducted at the higher end of the linear range of toxicity. In most cases, the animals do not have similar receptors, which makes these studies least relevant. This same argument holds for any PD and immunogenicity testing in animals. There is also little correlation with the human dose to make such studies redundant. The European Union and FDA have approved more than 100 products, and none of the products failed in animal toxicology testing because they cannot.

Clinical efficacy and safety studies comprise the most significant time and cost hurdles in the development of biosimilars, even though these studies do not add any assurance to the safety and efficacy evaluation. Hundreds of clinical efficacy and safety studies reported were conducted without the European Union or the FDA establishing that there is any “residual uncertainty” primarily to support the marketing of these products. However, if a biosimilar product fails to meet any of the studies stated above, particularly the clinical pharmacology, the FDA does not allow testing in patients because these studies can never resolve any “residual uncertainty” for the following reasons:

A single study in 1 of the several possible indications does not resolve uncertainty even where the mechanisms of action are cross-validated.

Efficacy studies require an arbitrary selection of differences in efficacy based on a clinical judgment that can vary widely.

A noninferiority study may allow a product with higher efficacy and, therefore, a possible higher safety risk.

Clinical markers are often unreliable and, in some populations like cancer patients, highly variable.

Many studies lose patients in critical care and rarely find naïve patients to reduce the variability and increase test power.

The statistical model of demonstrating that 2 products are not different is more complex than showing the efficacy of a product against a placebo.

None of the biosimilars tested for safety or efficacy failed the test. The clinical safety and efficacy are already subject to 

postmarket drug and biologic safety evaluations

In evaluating biosimilars, the FDA has created precise and scientifically significant vocabulary terms such as “no clinically meaningful difference” and “residual uncertainty” that are relevant and represent a creative approach to ensuring the safety of biosimilars. However, certain practices are needed to enable faster approval of biosimilars.

The following is a summary of my recommendations to the FDA:

Reduce comparative similarity assessment to relevant attributes.

Allow inclusion criteria in clinical pharmacology studies to reduce intersubject variability

Define “residual uncertainty” for every product evaluated and reject those where a resolution cannot be made.

Rely on postmarket evaluation for safety and efficacy instead of limited testing that cannot support removing any residual uncertainty.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars. 

Opinion: A Rational Approach to Establish Biosimilarity

An experiment with automatic prescribing of biosimilars at Texas Oncology resulted in a dramatic savings and increase in biosimilar vs originator usage rates, investigators reported at ASCO 2021.

Texas Oncology is a network of approximately 460 physicians and oncologists who serve patients with cancer in rural and urban communities throughout Texas. 

A central pharmacy team reviewed all prescriptions and substituted biosimilars for originator biologics, unless payers insisted otherwise or the relevant biosimilar was not in the practice formulary. Texas Oncology also compiled a weekly report identifying all patients who would benefit from switching to biosimilars, and substitutions were then made. In collaboration with McKesson Specialty Health, patient and clinician education was incorporated into the biosimilar usage effort to improve results.

Texas Oncology began the substitution in July 2020 with rituximab and followed up in September 2020 and October 2020 with bevacizumab and trastuzumab substitutions, respectively. By December 2020, utilization of biosimilars rose to 80% from 5% for rituximab, 88% from 9% for bevacizumab, and 74% from 8% for trastuzumab.

Investigators calculated the potential savings per administration at $550 for bevacizumab, $850 for trastuzumab, and $1400 for rituximab. “In 1 month alone, this project dramatically reduced cost by $4 million or 21% by conversion to these 3 biosimilars,” they wrote.

The investigators also predicted that additional savings would be possible by using multidose vials of biosimilar product rather than single-dose vials.

“Our comprehensive team approach successfully deploys therapeutic interchange of biosimilars for brand drugs in a community oncology practice which leads to substantial cost savings. This has real implications in controlling the total cost of care,” the authors of the study wrote.

Wilfong L, Dave N, Garey JS, et al. A successful model of biosimilar adoption in a community oncology practice. Presented at: ASCO 2021: June 3-7, 2021. Abstract 6514.

The substitution program was carried out in 2020 and yielded savings of $4 million in 1 month, investigators reported at ASCO 2021. 

Texas Oncology Reports Savings From Biosimilar Substitution Effort

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of May 31, 2021.

 for an ustekinumab biosimilar candidate (BFI-751) referencing Stelara, an immunosuppressant for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

 in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.

Number 3: Investigators reporting on insulin availability in the Philippines said affordability and access are inadequate for many in the country and recommended 

Number 2: Febrile neutropenia (FN) in patients undergoing chemotherapy has long been counteracted with granulocyte colony-stimulating factor (G-CSF) drugs. Models of G-CSF biosimilar use in this setting suggest not only significant savings but also potential for 

 in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

To read all of these articles and more, visit 

The Top 5 Biosimilar Articles for the Week of May 31

Clinicians should expect 1 out of 7 patients with rheumatic disease to reverse switch from biosimilar etanercept (BS-ETA) to the originator brand (OR-ETA), investigators concluded in a Netherlands study presented at EULAR 2021.

Authors of the study sought to evaluate the incidence of reverse switching among patients (N = 342) who were switched to BS-ETA from OR-ETA. They noted the findings are relevant because reverse switching reduces the savings achieved by switching patients to BS-ETA.

Prior, open label studies reported that from 2.7% to 7.4% of patients retransitioned to originator etanercept after switching to the biosimilar, the authors noted.

In their study, 9.4% of patients reverse switched to the originator by the 1-year mark following initiation on BS-ETA, whereas 69.7% persisted on the biosimilar agent. By the end of the follow-up period, 4.4 years from baseline, 47 patients or 13.7% had retransitioned to OR-ETA. The median time before reverse switching was slightly less than 6 months.

Expressed in odds ratios (OR), where a value greater than 1 indicates higher odds of an association, the univariate determinants for reverse switching were identified as initiating corticosteroids or intensifying immunomodulatory treatments (OR 2.37; 95% CI, 1.03-5.45) and the number of rheumatology department visits (OR 2.0; 95% C, 1.55-2.74).

In multivariate analysis, only rheumatology department visits remained significantly associated with reverse switching (OR 2.19; 95% CI, 1.60-3.01).

Investigators concluded not only that roughly 14% of patients would switch back to OR-ETA but also patients who visit the rheumatology department more often were at higher risk for retransitioning.

They did not identify the brand or brands of etanercept biosimilar included in the study. The originator is Enbrel, an Amgen product.

Meijboom RW, Gardarsdottir H, Becker ML, ten Wolde S, Egberts ACG, Giezen TJ. Incidence and determinants associated with retransitioning from etanercept biosimilar to etanercept originator. Presented at EULAR 2021: June 2-5, 2021. Poster 0637.

Investigators in the Netherlands observed that 13.7% of patients with rheumatic disease had switched back to etanercept originator at 4.4 years from baseline.