Use Of Biosimilars Research Articles

TNF-alpha inhibitors biosimilar use in France: a nationwide population-based study using the French National Health Data System

TNF-alpha inhibitors have revolutionized the therapeutic care in chronic inflammatory diseases. Several biosimilar products were commercialized at their patent expiry, substantially decreasing the cost of treatment. This longitudinal descriptive study aimed at assessing infliximab, etanercept and adalimumab biosimilar penetration rates using data of the French National Health Data System. A total of 207,118 new or prevalent users from the date of first biosimilar commercialization in France (respectively January 2015, May 2016 and October 2018) were included in the study and followed until September 30, 2021. Biosimilars represented respectively 78%, 46% and 53% of the overall initiations, and 94%, 66% and 60% last year’s initiations. A total of 46%, 19% and 17% of originator product prevalent users switched for a biosimilar during the follow-up. Biosimilar penetration rate was much higher for infliximab than for its counterparts, due to its hospital delivery modality. Biosimilar initiation and originator-to-biosimilar switch tended to be observed more in rheumatology than in the other specialties. Biosimilar use was mostly consistent across patient socio-demographic characteristics. Biosimilar initiation rate increased rapidly from their market arrival and originator-to-biosimilar switch rate remained moderate, highlighting the need and usefulness of political action and biosimilar use tracking.

Burden of Fatigue Among Patients with Ulcerative Colitis and Crohn's Disease: Results from a Global Survey of Patients and Gastroenterologists.

To assess the prevalence of fatigue and its association with disease activity and patient-reported outcomes among patients with ulcerative colitis (UC) or Crohn's disease (CD). Data from a cross-sectional survey conducted with gastroenterologists and their consulting adult patients with UC or CD were analyzed. Data were collected via gastroenterologist-completed patient record forms and patient-self completion forms. Patient demographics, clinical characteristics, disease activity and medication use were reported by the gastroenterologist, while current symptoms (fatigue, rectal urgency, abdominal pain, sleep disturbance), work productivity and the Short Inflammatory Bowel Disease Questionnaire (SIBDQ) were reported by the patient. Logistic regression models were used to identify measures associated with fatigue and expressed as odds ratio (OR) with 95% confidence interval. p < 0.05 was considered statistically significant. A total of 1057 patients with UC and 1228 patients with CD were included in this analysis. Fatigue was reported in 22.6% of UC and 26.0% of patients with CD. Higher proportion of patients with UC and fatigue had moderate/severe disease activity (p = 0.0001), had a higher Mayo score (5.0 vs. 4.0, p < 0.0001) and were unemployed (5.6% vs. 3.9%, p = 0.0149) compared to those without fatigue. In patients with CD reporting fatigue, a higher proportion were female (55.9% vs. 48.2%, p = 0.0193), were unemployed (5.8% vs. 4.9%, p = 0.0069), had moderate/severe disease (p < 0.0001) and had a higher mean Crohn's Disease Activity Index score (145.0 vs. 96.2, p < 0.0001) than patients without fatigue. Patients with UC and fatigue had higher mean level of pain (p < 0.0001) and sleep disturbance (p < 0.0001), whereas patients with CD and fatigue had lower SIBDQ scores (p < 0.0001) and greater work impairment (p = 0.0015) than patients without fatigue. Abdominal pain (OR: 2.01, p = 0.001) and use of immunomodulators (OR: 1.69, p = 0.006) increased the odds of having fatigue in patients with UC. In patients with CD, abdominal pain (OR: 2.29, p < 0.001) and use of biologics or biosimilars (OR: 2.02, p = 0.003) increased the odds of having fatigue. Fatigue is a common symptom among patients with UC or CD that is associated with higher levels of disease activity and decreased work productivity and is driven by various factors. A multidisciplinary approach may be needed to manage fatigue.

The Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance

The over-production of TNF-α can lead to chronic inflammation and organ damage in immune-mediated inflammatory diseases (IMID), such as rheumatoid arthritis (RA), axial spondyloarthritis, psoriasis, and inflammatory bowel disease (IBD). Anti-TNF therapy is generally considered to be an effective, well-tolerated treatment option for the management of chronic inflammation in these conditions. Over the past decade, patents for the original reference anti-TNF agents have expired, permitting the development of anti-TNF products that are biologically similar, termed ‘biosimilar’, to the original reference product. Differences in the approval process mean that biosimilars are often available to healthcare services at a considerably lower cost compared with the reference products, providing an opportunity to improve patient access to the benefits of anti-TNF therapy. However, despite the spreading use of biosimilars across healthcare services, some clinicians remain reluctant to prescribe them. The gradual accumulation of long-term data on the real-world use of biosimilars, and an improved understanding of the development and approval process for these products, may help to increase clinicians’ confidence to increase usage of biosimilars. This mini review summarises the current status of anti-TNF biosimilars in clinical practice, including the requirements for regulatory approval, real-word evidence for their equivalence to novel anti-TNFs, guidelines for their use, and challenges to their acceptance by both clinicians and patients.

Provider and patient knowledge gaps on biosimilars: insights from surveys

Beyond the legal and regulatory limitations associated with biosimilar availability in the United States, the adoption of biosimilars is contingent on the willingness of health care providers (HCPs) to prescribe them and of patients to accept them. In this dynamic market, it is of paramount importance to understand the current awareness, attitudes, and preferences of a broad spectrum of stakeholders if uptake of biosimilars is to be optimized. In this article, we highlight knowledge gaps among US HCPs and patients regarding biosimilars for immune-mediated inflammatory diseases as assessed in published survey literature over the last 5 years. Although HCP familiarity and understanding of biosimilars appears to have improved over the last 5 years, survey data suggest that some physicians and pharmacists still approach use of biosimilars with caution owing to concerns regarding nonmedical switching, interchangeability, pharmacist-led substitution, and the extent of any cost savings. Patients understand the potential cost benefits of biosimilars but share many of the HCPs' concerns. A large majority of patients were also concerned that biosimilars would not treat their disease as well as the reference product and that switching may cause more adverse effects. Consequently, nonmedical switching is a major concern for patients, with the majority reporting that they would attempt to avoid a switch. Although patients trust their physicians' treatment recommendations and express confidence in biosimilars, they have mixed views on automatic substitution by pharmacists. The areas of concern identified can be used to guide further education programs for HCPs and patients, and, in doing so, improve biosimilar uptake.

Identification of Barriers Preventing Biosimiliar Oncology Medication Adoption.

(1) Background: A biosimilar is a biologic medical product that has been approved by the United States Food and Federal Drug Administration (FDA) and is an almost identical copy of an original biologic product yet manufactured by a different company. Biosimilars are often assumed to be the same as generic medications, while often made from living organisms. Through clinical trials, biosimilars have been shown to be both as safe and as effective as their originator products. Biosimilars have also proven they can reduce the costs to both insurance companies and patients in many circumstances. However, despite their cost savings, biosimilar manufacturers continue to face barriers in having oncologists and cancer centers prescribe them for their patients. This review aims to identify barriers associated with medical provider prescriptive behaviors related to biosimilars for patients. (2) Methods: Reviewers analyzed 27 articles and identified common themes. (3) Results: After a thorough literature review, the researchers identified seven barriers to prescribing of biosimilars: physician comfort in originators instead of biosimilars, patient reluctance to switch from a current biologic to a biosimilar, provider profits associated with an originator biologic, lack of stakeholder education on biosimilars, lack of provider team knowledge of biosimilars, lack of knowledge surrounding the biosimilar FDA approval process, and hesitancy to stock multiple drugs for a specific indication. (4) Conclusions: This review's findings of identified barriers to use of biosimilars provides insight for healthcare providers and organizations surrounding prescribing practices and potential treatment benefits for cancer patients who may benefit from biosimilar treatment medications.

Comparative cost savings of biosimilar and dose rounding utilization in oncology care.

The exponential rise in cancer costs has led many centers to utilize dose rounding to the nearest vial size when the difference in dose is ≤10% to decrease costs. The recent approval of several biosimilar products has presented another opportunity to mitigate the rising costs of oncology care. Scarce information exists about the expected cost savings of combining dose rounding strategies (DRS) with biosimilar use (BU). We therefore assessed the cost savings of combining DRS and BU. Electronic health record data for two health systems in Rhode Island were used to identify patients who received ≥1 of trastuzumab, trastuzumab-anns, bevacizumab, or bevacizumab-awwb from October 1, 2015 to September 1, 2020. Costs were estimated using Medicare drug pricing. Multivariable generalized estimating equations adjusting for age, gender, presence of metastases, dosing weight, and dose administered were used to compare costs per dose between the four exposure groups: DRS + BU, DRS only, BU only, and neither DRS or BU. A total of 1156 patients were administered 15,145 doses of drug. After covariate adjustment, average savings per dose was greatest in the DRS + BU group (vs. the neither DRS nor BU group); $331 for trastuzumab and $497 for bevacizumab. Combining dose rounding with biosimilar substitution for trastuzumab and bevacizumab resulted in significant cost savings per dose and should be implemented by healthcare systems.

Utilization, user characteristics, and adverse outcomes of bevacizumab products in oncology in a distributed research network.

400 Background: Bevacizumab (Avastin), an anti-angiogenic agent, was approved for various oncologic indications in 2004 in the US. Two biosimilars, bevacizumab-awwb (Mvasi) and bevacizumab-bvzr (Zirabev), were on the market 2017 and 2019, respectively. Real-world data on adverse events for bevacizumab biosimilars is limited. Methods: We conducted a retrospective cohort study using the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) distributed database to evaluate utilization patterns, patient characteristics, and prespecified adverse events of interest for the originator bevacizumab relative to its biosimilars in oncology among users 21 years of age and older between January 1, 2010, to December 31, 2020. Oncology indications included colon, lung, and gynecologic (cervical, uterine, and ovarian) cancers. Adverse events (AEs) of interest were arterial thromboembolism (ATE), congestive heart failure (CHF), gastrointestinal perforation, stroke and acute myocardial infarction (AMI), and venous thromboembolism (VTE). The study analyzed biosimilars collectively, which include bevacizumab-awwb and bevacizumab-bvzr. Results: Both bevacizumab originator and biosimilar users for colon cancer were mostly male (55%), had a mean age of 61 years, and a mean Charlson/Elixhauser combined comorbidity score from 7.0 to 8.0. Among patients with lung cancer users, 53% were female with an overall mean age of 64 years and comorbidity scores from 6.4 to 7.5. Patients with gynecologic cancers had mean age of 63 years, and comorbidity scores from 6.1 to 6.7. Overall, oncologic bevacizumab use increased by 19% over time. Of the 24,044 total episodes from 2010 to 2020, AEs included ATE (2,560 events, 11%), CHF (2,092 events, 9%), gastrointestinal perforation (2,858 events, 12%), stroke/AMI (399 events, 2%), and VTE (4,447 events, 19%). AE rates were comparable between the originator and biosimilars: 7% and 8% for ATE, 5% and 4% for CHF, 9% and 8% for gastrointestinal perforation, 0.6% and 1% for stroke and AMI, and 10% and 8% for VTE, respectively. From 2019 to 2020, biosimilar use increased from 6% to 49% of total bevacizumab utilization for patients with colon cancer, from 2% to 36% for patients with lung cancer, and from 2% to 38% for patients with gynecologic cancers. Conclusions: Bevacizumab utilization increased across all oncology indications evaluated during the study period. From 2019 to 2020, utilization for biosimilars relative to the originator increased. As there are limited data available on bevacizumab biosimilar use in real world settings, future research should be conducted to see if utilization for biosimilar products continues to rise as well as safety over time.

S724 Insurance Companies’ Poor Adherence to ACG/AGA Guidelines for Moderate to Severe Ulcerative Colitis and Crohn’s Disease Management

Introduction: Management of moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD) has shifted from step-up therapy to induction of remission with a biologic agent based on disease severity. We sought to assess if current insurance company policies meet the latest guidelines from the ACG and AGA for UC and CD management. Methods: The top 50 insurance companies were searched for publicly available policy information for infliximab, adalimumab, vedolizumab, tofacitinib, and ustekinumab. Data extracted included authors, date of last revision, citation of AGA/ACG guidelines, and policy requirements. Additionally, data regarding need to fail conventional therapy, use of biosimilars, and use of 1st line biologic agents was obtained. The data was compared to the 2018 ACG and 2020 AGA guidelines for UC, and the 2019 ACG and 2021 AGA guidelines for CD. Results: Of the top 50 insurance companies, 48 provided health coverage. Of those, 33 (72.34%) had publicly accessible policies on the coverage of biologics. No authors of the policies were listed. ACG/AGA guidelines were directly quoted or cited in 70.6% of policies. Policies were updated from 1/1/2016 to 5/31/2022. Of the 34 policies that were analyzed, only 58.8% of policies were consistent with the ACG guidelines for CD vs 8.8% to AGA guidelines (Table). Additionally, only 14.7% and 17.7% of policies permitted any first-line biologic therapy in CD and in UC respectively. Conclusion: As of 2022, insurance companies that comprise nearly 80% of the market are yet to adopt the most current guidelines for IBD management. Nearly every insurance company requires the failure of “conventional” therapies such as 5-ASAs, immunomodulators, and corticosteroids. The time required to determine therapeutic failure was inconsistent – ranging from 7 days to 6 months. The large difference between adherence to ACG vs AGA guidance for CD is due to the difference in recommendations for use of an immunomodulator vs anti-TNF as first line agent, as well as length of treatment with corticosteroids before failure (short term therapy vs 3-5 days). The second most common reason for guideline non-adherence was the inability to use immunomodulators concurrently with biologics. Finally, first-line biologic medications were limited primarily to adalimumab or infliximab. Further work is needed to better understand the implications of these inconsistencies between insurance companies and formal medical guidelines on outcomes for patients with moderate-to-severe UC and CD. Table 1. - Adherence to Published Professional Society Guidelines Metric Ulcerative Colitis Crohn's disease ACG Guidelines (2018, 2019) 3/34 (8.8%) 20/34 (58.8%) AGA Guidelines (2020, 2021) 3/34 (8.8%) 2/34 (5.8%) Any first line biologic (infliximab, adalimumab, vedolizumab) 5/34 (14.7%) 6/34 (17.7%) Requirement to fail at least one conventional therapy 31/34 (91%)* 31/34 (91%)** *Certain policies have exceptions including hospitalization for UC.**Certain policies have exceptions including fistulizing disease for CD.

Determinants of prescribing decisions for off-patent biological medicines in Belgium: a qualitative study

BackgroundA competitive market for off-patent biologicals leads to more affordable and high-quality healthcare. In recent years, Belgium has been characterized by its low use of biosimilars and by its shifts from off-patent biologicals toward new alternative therapies. Yet, the prescribing decisions involved in these observations are poorly understood. This study aims to better understand prescribing choices among Belgian physicians in the ambulatory care setting.MethodsThis study consisted of two phases. First, a scoping literature review to identify determinants of prescribing choices was conducted. Scientific databases (Embase and PubMed) were searched until 4 November 2021. Second, the nominal group technique (NGT) was employed during focus group discussions with Belgian physicians to consider and validate these determinants for off-patent biologicals in the Belgian context. The qualitative data resulting from the literature review and focus group discussions were analyzed using the thematic framework method.ResultsFifty-three scientific articles that discussed elements that determine prescribing choices were identified. Out of these, 17 determinants of prescribing choices were found. These were divided into five categories: (1) product-related, (2) physicians’ personal, (3) healthcare system-related, (4) patient-related, and (5) determinants related to the pharmaceutical company or brand. Nineteen Belgian physicians from different therapeutic areas that regularly prescribe biologicals then participated in focus group discussions. Using the NGT, the group discussions revealed that prescribing choices for off-patent biologicals are determined by a complex set of elements. Clinical data, geographical region, working environment, pharmaceutical marketing, patient profile, clinical guidelines, and preference of key opinion leaders (KOL) were considered most influential. Physicians indicated that the importance of these determinants differs depending on product classes or therapeutic domain.ConclusionsMultiple elements determine the choice of an off-patent biological or biosimilar product. The importance of each of these determinants varies depending on the context in which the prescribing choice is made. To increase the prescription of best-value biologicals in the Belgian ambulatory care, a set of synergistic measures is required including information for healthcare providers (HCP) and patients, prescribing feedback, prescribing targets, tangible incentives, KOL involvement, guidelines regarding pharmaceutical promotion, and regular revision of reimbursement modalities.

Post-switch Effectiveness of Etanercept Biosimilar Versus Continued Etanercept in Rheumatoid Arthritis Patients with Stable Disease: A Prospective Multinational Observational Study.

To better inform clinicians about the use of etanercept biosimilar (SB4) in patients with rheumatoid arthritis (RA), COMPANION-B, a prospective real-world observational study, evaluated the effectiveness of the voluntary switch from originator (etanercept, ETN) to SB4 in patients with stable RA (low-disease activity/remission). The study recruited adult patients (18years or older) with RA (2010 American College of Rheumatology criteria) prescribed ETN as their first or second biologic for at least 6months across 14 sites in Canada and five in Australia. Patients had stable disease (Disease Activity Score-28 using erythrocyte sedimentation rate [DAS28-ESR] less than 3.2) at enrollment with no evidence of flare within the previous 3months. Concomitant disease-modifying antirheumatic drugs (DMARDs) were permitted. Patients could elect to continue ETN or voluntarily switch to SB4 in consultation with their doctors. The primary effectiveness measure was the proportion of patients with disease worsening (defined as a DAS28-ESR increase of at least 1.2 from baseline and minimum score of at least 3.2 or a defined modification in RA treatment) during 12months of follow-up. The secondary effectiveness measure was the proportion of patients with disease worsening at month6. Serious adverse events (SAEs) and non-serious adverse reactions (NSARs) were recorded. Of 163 patients enrolled, 109 elected to continue on ETN and 54 switched to SB4; 65.8% of patients received non-biologic DMARD(s), 52.6% methotrexate, and 10.5% oral corticosteroid(s). At month12, the proportion of patients with disease worsening was comparable in the ETN group (22.8% [95%CI 15.0-32.2]) and SB4 group (17.6% [95%CI 8.4-30.9]). Similarly, the proportions of patients with disease worsening were also comparable at month6 (ETN: 7.9% [95%CI 3.5-15.0]; SB4: 7.8% [95%CI 2.2-18.9]). SAEs were low and similar across both groups (ETN: 8.7%; SB4: 5.7%). NSARs were slightly higher in the SB4 vs. ETN group (13.2% vs. 2.9%). SB4 demonstrated comparable effectiveness to ETN over 12months in patients with stable RA who voluntarily switched to the biosimilar in a real-world setting.

Mise en place de consultations pluridisciplinaires pour des patients atteints de rhumatisme inflammatoire chronique et traités par biothérapie sous-cutanée : bilan à un an et perspectives

Biologics (bDMARDs) have revolutionized the prognosis of patients with inflammatory arthritis, but are not without serious side effects. The patient must be able to identify them, acquire self-care abilities or skills and adhere to their treatment. Multidisciplinary consultations, including a pharmaceutical consultation could improve the care of these patients. The pharmaceutical presence make it easier to switch to a biosimilar with etended patient support thanks to the community-hospital network. The return on investment is possible thanks to the more frequent use of biosimilars and the pricing of this type of consultation by the "Forfait de Prestation Intermédiaire". Eligible patients are patients with rheumatoid arthritis or spondyloarthritis, treated with subcutaneous bDMARDs. The criteria assessed were patient's knowledge of their biotherapy using the Biosecure score, their medication adherence using the CQR-5, the total of switch to biosimilars perform and the financial statement of the consultations. An assessment of the actions deployed for the community-hospital network. Two hundred and ninety-five patients (47.4%) benefited multidisciplinary consultation. The mean score of the Biosecure score was 69.6/100 (moderate knowledge) and 261 patients (88.5%) were highly adherent. 57 patients (73%) accepted the switch to biosimilar. 197 pharmacy were contacted, all of witch for patients who receive the switch. Overall patient's satisfaction was 26.9/28. Multidisciplinary consultations with involvement of the pharmacist should optimized patient care and the management of outpatients treated with bDMARDs. Patients have already expressed their satisfaction with this course of care and the return on investment is positive.

Switching Among Biosimilars: A Review of Clinical Evidence.

Biological medicines have improved patients’ outcomes, but their high costs may limit access. Biosimilars, alternatives that have demonstrated high similarity in terms of quality, safety, and efficacy to an already licensed originator biological product, could increase competition and decrease prices. Given the expanding number of biosimilars, patients may switch from originator to biosimilar or among biosimilars. Randomized trials and observational studies conducted with multiple biosimilars over many disease areas confirmed the safety and efficacy of switching from originator to biosimilar. This study summarizes evidence on switching between biosimilars for which there are concerns to provide future guidance. A systematic search (MEDLINE, Embase, and Cochrane Library) for studies on anti-TNF agents, assessing clinical efficacy and safety of biosimilar-to-biosimilar switch in chronic inflammatory diseases, was performed. We retrieved 320 records and included 19 clinical studies. One study with historical control compared switching between biosimilars to maintenance of the same biosimilar. Ten were controlled cohort studies comparing switching between two biosimilars vs. switching from originator to a biosimilar or vs. multiple switches. Eight were single-arm cohort studies, where participants switched from one biosimilar to another, and the outcomes were compared before and after the switch. Overall, these studies did not highlight significant concerns in switching between biosimilars. Therefore, switching studies seem difficult to perform and unnecessary with the body of evidence suggesting no real problems in practice coupled with stringent regulatory requirements. Monitoring the use of biosimilars in clinical practice could support clinical decision-making, rational use of biological medicines, and help to further realize possible savings.

Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer.

Trastuzumab is a monoclonal antibody used in the treatment of breast cancer in cases where the tumor overexpresses the HER2 receptor, a cell membrane receptor activated by the epidermal growth factor. Intravenous and subcutaneous administration of trastuzumab have comparable clinical and pharmacological characteristics, but trastuzumab biosimilars are currently only available in intravenous form. Trastuzumab biosimilars are ultimately preferred by a proportion of patients, especially in cases where co-administration of other chemotherapeutic agents, such as trastuzumab and tucatinib, a small molecule of tyrosine kinase inhibitor, is required in patients with HER-positive metastatic breast cancer. Oncologists should be well-aware of the advantages of intravenously administered trastuzumab biosimilars over subcutaneous administration, certainly also taking into account the patient’s preferences. Further cost-effectiveness analyses will be very important, along with expectations regarding successful concomitant subcutaneous administration of trastuzumab with other anticancer drugs, such as pertuzumab. This systematic review describes and analyzes the so-far published studies concerning the use of the available trastuzumab biosimilars in HER-positive early and metastatic breast cancer in terms of efficacy, safety, and cost–benefit ratio. An attempt was also made to draw some conclusions and to comment on future needs and perspectives.

Production of an anti-TNFα antibody in murine myeloma cells by perfusion culture.

Infliximab is a mouse/human chimeric IgG1 monoclonal antibody which recognizes the proinflammatory cytokine, tumor necrosis factor α (TNFα), and inhibits receptor interactions, thereby decreasing inflammation and autoimmune response in patients. This monoclonal antibody has been successfully used to treat rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. However, the high treatment cost limits patient access to this biotherapy. One alternative to this problem is the use of biosimilars. In this work, we describe the stable expression and physicochemical characterization of an anti-TNFα antibody. While infliximab is produced in recombinant murine SP2/0 cells, our anti-TNFα IgG antibody was expressed in recombinant murine NS0 myeloma cells. The best anti-TNFα antibody-expressing clone was selected from three clone candidates based on the stability of IgG expression levels, specific productivity as well as TNFα-binding activity compared to commercial infliximab. Our results indicate that the selected cell clone, culture medium, and fermentation mode allowed for the production of an anti-TNFα antibody with similar characteristics to the reference commercially available product. An optimization of the selected culture medium by metabolomics may increase the volumetric productivity of the process to satisfy the demand for this product. Further experiments should be performed to evaluate the biological properties of this anti-TNFα antibody. KEY POINTS: • An anti-TNFα antibody was produced in NS0 cells using perfusion culture. • A proprietary chemically defined culture medium was used to replace commercially available protein-free medium. • The purified anti-TNFα antibody was comparable to the reference marketed product.

Real-life experience of infliximab biosimilar in pediatric-onset inflammatory bowel disease: data from the Sicilian Network for Inflammatory Bowel Disease.

To provide data on the use of infliximab biosimilars (IFX-BioS) in children with inflammatory bowel disease (IBD). A multicenter, observational, retrospective study was performed among the cohort of the Sicilian Network for IBD. All consecutive IBD children who had at least completed the induction with IFX-BioS from its introduction in Sicily to January 2021 were enrolled. Clinical remission at weeks 14 and 52, treatment persistence, and adverse events were the study outcomes. Eighty-seven patients [Crohn's disease (CD): 57.5% and ulcerative colitis (UC): 42.5%] were included: 75 (86.2%) were antitumor necrosis factor-α (anti-TNF-α) agent naïve, while three (3.45%) were switched from the originator to IFX-BioS. Twenty (23%) patients were multiply switched from the biosimilar CT-P13 to SB2 or GP1111 or vice versa. The median follow-up time was 15 months. Clinical remission was achieved by 55.2 and 65.5% of patients at weeks 14 and 52, respectively, with no differences between CD and UC. Dose escalation was needed in 8.0 and 35.7% of patients during induction and maintenance, respectively. Nine adverse events occurred (incidence rate: 6.13/100 person-year). Treatment persistence was 90.8% at 1 year and 75.7% at 2 years (patients on IFX-BioS at 2 years, n = 28). The risk of treatment discontinuation was higher in patients with extraintestinal manifestations ( P = 0.018) and in those who were nonnaïve to anti-TNF-α ( P = 0.027). This is the largest cohort of pediatric IBD patients treated with IFX-BioS. Real-life data show that IFX-BioS is efficacious in IBD children, with high percentages of treatment persistence and a low incidence of nonserious adverse events.

Biosimilar Use and Switching in Belgium: Avenues for Integrated Policymaking.

Background: By improving the affordability and accessibility of biologicals, biosimilar competition provides important benefits to healthcare systems and patients. In Belgium, biosimilar uptake and competition is limited compared to other European markets. Whereas other countries have initiated structured biosimilar introduction or switching plans, no such framework or guiding principles are yet available in Belgium. Objective: This study aims to develop recommendations that can inform policy action in Belgium on biosimilar use, especially in the context of switch decision-making, and this by drawing from the perspectives of healthcare professionals involved in procuring, prescribing, switching and dispensing biologicals including biosimilars. Methods: This study made use of the consensus-building Nominal Group Technique, consisting of a three-step process 1) individual grading, 2) three structured Focus Group Discussions, 3) final individual grading involving an expert group of Belgian healthcare professionals (physician specialists and hospital pharmacists). Results: Participants (n = 13) voiced challenges with the use of biosimilars and switching in practice, and a lack of incentives to use them. Six concrete areas for policy development to support stakeholders with biosimilar use and switch decision-making were identified: 1) address stakeholder hesitations regarding (multiple) switching, 2) provide meaningful incentives, 3) guide healthcare professionals with product decision-making, 4), align practical product modalities when possible, 5) involve healthcare professionals in policy making, and 6) provide practical switch support and patient information material, particularly in the ambulatory care setting. For each area, specific consensus-based recommendations were developed. Furthermore, a set of switch management and patient communication principles was derived, including amongst others, generating buy-in from involved stakeholders prior to switching and communicating with a one-voice message. Conclusion: Without cohesive actions to reduce hurdles and without tangible benefits or steering mechanisms, changes in biosimilar use are unlikely in Belgium. To overcome this and stimulate market competitiveness, this study advances a set of concrete policy recommendations. At large, policy makers should develop an integrated policy framework, with a pro-active, best-value biological implementation roadmap that provides guidance and compelling measures to incentivize healthcare professionals to use biosimilars. Particular consideration should go to the ambulatory care setting, since drivers for biosimilar use are quasi absent in this context.

Uptake of Oncology Biosimilars: Managed Care Strategies to Improve Value-Based Care Systems

The use of biosimilars in oncology and as supportive agents for patients with cancer has introduced an important opportunity to expand access to cost-effective care, but their utilization remains inconsistent and is influenced by a variety of factors. Promoting the uptake of biosimilars across healthcare systems relies on improving perception and education about biosimilars, which involves multiple stakeholders, including pharmacists, providers, and patients. Clinicians and managed care professionals must consider comparative analytical studies, clinical efficacy data, and reductions in costs of care associated with biosimilars when establishing protocols for their inclusion within formularies. Real-world switch studies in oncology biosimilars that have demonstrated bioequivalence provide basis to support efficacy and safety to transition to a biosimilar product. Incorporating oncology biosimilars into treatment pathways will be an important next step in providing value-based care to patients with cancer.

EE505 Canada's Evolving Market for Biosimilars and What It Means for Payers

Potential savings from biosimilars are a subject of keen interest internationally, with a particular relevance for Canadians. Canada is a relatively high-use and high-price market for biologics and the increased use of biosimilars offers a significant opportunity for cost savings for Canadian payers. Recent policy changes to promote biosimilar switching are expected to result in significant cost reductions for these classes of biologics in Canada, helping to offset the pressure from new higher-cost medicines in coming years. As these initiatives are implemented at the provincial level, Canada offers a unique model to observe the impacts of variations in approach and timing across jurisdictions. The analysis aims to identify potential opportunities in the Canadian biosimilars market in comparison with international practices.

HPR12 Assessment of the French National Experimentation for Incentivising Hospital Prescriptions of Adalimumab Biosimilars Delivered in Retail Pharmacies

Regarding the low penetration of biosimilars drugs in the French market, the government introduce two incentives to increase biosimilar use. First, the “general case” redirects 20% of the price difference between reference product and its biosimilar to hospitals for every biosimilar delivered in community pharmacy from these hospital’s prescriptions. Second, the “experimental case” increases the premium to 30% by specifically targeting prescribing hospital clinical units for every biosimilar delivered in community pharmacy from these clinical unit’s prescriptions.

HPR28 Assessment of the French National Experimentation for Incentivising Hospital Prescriptions of Etanercept Biosimilars Delivered in Retail Pharmacies

Regarding the low penetration of biosimilars drugs in the French market, the government introduce two incentives to increase biosimilar use. First, the “general case” redirects 20% of the price difference between reference product and its biosimilar to hospitals for every biosimilar delivered in community pharmacy from these hospital’s prescriptions. Second, the “experimental case” increases the premium to 30% by specifically targeting prescribing hospital clinical units for every biosimilar delivered in community pharmacy from these clinical unit’s prescriptions.