Markers that allow for the selection of tailored treatments for individual patients with inflammatory bowel diseases (IBD) are yet to be identified. Our aim was to describe trends in real-life treatment usage. For this purpose, patients from the ENEIDA registry who received their first targeted IBD treatment (biologics or tofacitinib) between 2015 and 2021 were included. A subsequent analysis with Machine Learning models was performed. The study included 10,009 patients [71% with Crohn\'s disease (CD) and 29% with ulcerative colitis (UC)]. In CD, anti-TNF (predominantly adalimumab) were the main agents in the 1st line of treatment (LoT), although their use declined over time. In UC, anti-TNF (mainly infliximab) use was predominant in 1st LoT, remaining stable over time. Ustekinumab and vedolizumab were the most prescribed drugs in 2nd and 3rd LoT in CD and UC, respectively. Overall, the use of biosimilars increased over time. Machine Learning failed to identify a model capable of predicting treatment patterns. In conclusion, drug positioning is different in CD and UC. Anti-TNF were the most used drugs in IBD 1st LoT, being adalimumab predominant in CD and infliximab in UC. Ustekinumab and vedolizumab have gained importance in CD and UC, respectively. The approval of biosimilars had a significant impact on treatment.

BACKGROUND: Biosimilars are biologic drugs that have the potential to increase the efficiency of healthcare spending and curb drug-related cost increases. However, their introduction into hospital formularies through initiatives such as non-medical switching must be carefully orchestrated so as not to cause treatment discontinuation or result in increased health resource utilization, such as additional visits or laboratory tests, among others. This retrospective cohort study aims to assess the impact of the introduction of CT-P13 on the healthcare expenditures of patients who were treated with originator infliximab or CT-P13.
METHODS: Gastroenterology, immunoallergology and rheumatology patients treated between September 2017 and December 2020 at a university hospital in Western Switzerland were included and divided into seven cohorts, based on their treatment pathway (i.e., use and discontinuation of CT-P13 and/or originator infliximab). Costs in Swiss francs were obtained from the hospital\'s cost accounting department and length of stay was extracted from inpatient records. Comparisons of costs and length of stay between cohorts were calculated by bootstrapping.
RESULTS: Sixty immunoallergology, 84 rheumatology and 114 gastroenterology patients were included. Inpatient and outpatient costs averaged (sd) CHF 1,611 (1,020) per hospital day and CHF 4,991 (6,931) per infusion, respectively. The mean (sd) length of stay was 20 (28) days. Although immunoallergology and rheumatology patients had higher average costs than gastroenterology patients, differences in costs and length of stay were not formally explained by treatment pathway. Differences in health resource utilization were marginal.
CONCLUSIONS: The introduction of CT-P13 and the disruption of patient treatment management were not associated with differences in average outpatient and inpatient costs and length of stay, in contrast to the results reported in the rest of the literature. Future research should focus on the cost-effectiveness of non-medical switching policies and the potential benefits for patients.

Data about biosimilar Peg-filgrastim (bioPEG) in autologous stem cell transplant (ASCT) are still scarce. The aim of this study has been to assess efficacy and safety of bioPEG among lymphoma and myeloma patients undergoing ASCT, comparing these data with historical controls receiving other G-CSFs. Furthermore, an economic evaluation has been included to estimate the savings by using bioPEG. This is a prospective cohort study comparing lymphoma and myeloma patients undergoing ASCT and receiving bioPEG (n = 73) with three historical consecutive cohorts collected retrospectively who received other G-CSFs (Lenograstim - Leno - n = 101, biosimilar Filgrastim - bioFIL n = 392, and originator Peg-filgrastim - oriPEG n = 60). We observed a significantly shorter time to neutrophils and platelet engraftment (p < 0.001) in patients treated with bioPEG and oriPEG. Moreover, patients who received bioPEG showed a shorter hospitalization time (p < 0.001) and a lower transfusion need (p < 0.001). We did not observe any significant difference in terms of transplant-related mortality, mucositis, and diarrhea among the four groups. No serious adverse events were associated with bioPEG. Similar data were obtained after running a stratified analysis for lymphomas and myeloma separately conducted by using a propensity score matching. The average total cost per patient of bioPEG was € 18218.9 compared to € 23707.8, € 20677.3 and € 19754.9 of Leno, oriPEG, and bioFIL, respectively. In conclusion, bioPEG seems to be as effective as the originator and more effective than short-acting G-CSFs in terms of post-transplant engraftment in myeloma and lymphoma patients undergoing ASCT. Moreover, bioPEG was cost-effective when compared with the other G-CSFs.

Payment for oncology care is increasingly moving from fee-for-service to value-based payment (VBP). VBPs are agreements in which providers are held accountable for total cost of care (TCOC) through risk-sharing arrangements with payers that tie reimbursement levels to TCOC benchmarks. Oncology biosimilars may play an important role in managing financial risk in the VBPs like Medicare\'s Oncology Care Model (OCM), but there has been limited research in this area. The objective of this study is to estimate the impact of biosimilar adoption on TCOC and oncology provider financial performance under the terms of the Medicare OCM.
We conducted a population-based simulation study using the Medicare Limited Data Set (LDS) and the methodology of Medicare\'s OCM. The primary outcome was the simulated average change in TCOC per 6-month episode of care attributable to use of biosimilars as an alternative to reference products. The study population consisted of episodes of care in 2020 and using the reference product or corresponding biosimilar for bevacizumab, rituximab, trastuzumab, epoetin alfa, filgrastim, or pegfilgrastim. TCOC was calculated for each episode of care with use of reference products only and compared with TCOC with corresponding biosimilars. The simulation calculated TCOC outcomes in cohorts of 100 episodes sampled from the Medicare LDS study population using a Monte Carlo simulation with 10,000 iterations.
Among the total of 8281 6-month oncology care episodes identified in the study period (initiating January 2020 to July 2020) in Medicare claims, 1586 (19.2%) episodes met OCM and study criteria and were included. Applying the simulation methods to these observed episodes, biosimilar substitution reduced mean TCOC per episode by $1193 (95% CI $583-1840). The cost reduction from biosimilars represented 2.4% of the average TCOC benchmark and led to a 15% reduction in the risk of providers needing to pay recoupments to Medicare for exceeding TCOC benchmarks.
On the basis of our simulation study using observed Medicare claims and OCM criteria, we found that biosimilar substitution for reference products can significantly lower episode TCOC and improve provider financial performance under the terms of the largest value-based payment model implemented to date.

Bevacizumab (Bvz) is the most preferred recombinant humanized monoclonal antibody in biosimilar development due to its prominence as a standard treatment in the oncology space. Therapeutic monoclonal antibodies are typically more complex and unlikely to produce a replica. As a result, regulatory agencies allow approval of biosimilars that differ structurally and functionally from their reference product, but these differences should not have any clinical significance. To identify these significant discrepancies, it is essential to perform a thorough characterization of critical product attributes both in real-time and after storage until the product\'s expiration. In the present study, two Bvz biosimilar brands (Bio-1 and Bio-2) marketed in India were evaluated and compared with the reference product Avastin® to assess their degree of similarity. A comprehensive physicochemical characterization of biosimilars and reference product was performed using orthogonal techniques including LC-ESI-QTOF, MALDI-TOF, FTIR-ATR, iCIEF, rCE, nrCE, UV280, and RP-HPLC. Furthermore, Bvz formulations under study were subjected to various stress conditions of thermal (elevated temperature 50 ± 2 °C), chemical (acidic pH 3.0 ± 0.2, neutral pH 7.0 ± 0.2, and basic pH 10.0 ± 0.2), and mechanical (agitation 200 rpm) for comparative stability evaluation. Any alteration in the secondary structure of the native protein was detected and quantified using far-UV circular dichroism (CD), indicating an average of 15% and 11% loss in native antiparallel β-sheet conformation respectively in Bio-1 and Bio-2 upon exposure to elevated temperature and high pH. Additionally, covalent or non-covalent aggregates formed as a function of elevated temperature and agitation were quantified using SEC-MALS.

BACKGROUND: SB5 is an EMA-approved adalimumab biosimilar, having demonstrated bioequivalence, equivalent efficacy, and similar safety and immunogenicity to the reference product.
OBJECTIVE: Describe patient training and satisfaction using patient-reported outcome measures (PROMs) and assess their impact on 12-month persistence on SB5.
METHODS: The observational PERFUSE study included 318 Crohn\'s disease (CD) patients and 88 ulcerative colitis (UC) patients in 27 sites across France between October 2018 and December 2020. PROMs were collected at 1-month post-baseline using an online questionnaire (ePRO) designed with patient associations. Treatment persistence was collected during routine visits (up to 15 months post-initiation). Results are presented by prior experience with subcutaneous biologics and training in proper use of the injection device.
RESULTS: 57.1% (n = 145) and 44.1% (n = 67) of naïve and pre-treated patients, respectively, answered the ePRO. Naïve patients were offered training more often (86.9% vs 31.3% respectively, p < 0.05), with disparities between sites. All subgroups\' satisfaction scores were high. 12-month persistence on SB5 was significantly higher for respondents than for non-respondents (68.0% [60.9; 74.1] vs 52.3% [44.5; 59.6]; p < 0.05) and in patients with a better perception of their illness (OR=1.02, [1.0; 1.05]; p < 0.05).
CONCLUSIONS: Early patient questionnaires may be useful to identify patients at higher risk of treatment discontinuation.

UNASSIGNED: Pharmacists\' knowledge of the differences in the characteristics between generic drugs and biosimilars is essential to ensure good practice and lower pharmaceutical bills.
UNASSIGNED: This study aimed to evaluate community pharmacists\' knowledge and perception of using and substituting biosimilars and generic drugs.
UNASSIGNED: A pilot cross-sectional study was performed over 2 months (August-September 2022) targeting community pharmacists in their work site.
UNASSIGNED: Data were collected using a uniform survey given to 75 pharmacists. Afterward, a knowledge score was generated by summing several individual scores of statements regarding generic drugs and biosimilars.
UNASSIGNED: Overall, pharmacists had moderate to low knowledge scores, namely, with the statements tackling biosimilars. No significance was reported between these scores and their general characteristics. As regards their substitution, most pharmacists agreed to substitute generic drugs if the brand was not available, while the doctor\'s approval was crucial for biosimilar switching. Most participants perceived equal effectiveness of generic drugs but similar to a lower one for biosimilars compared to the reference medication. Pharmacists highlighted the need to include generic drugs and biosimilars in the continuing education program and workshops.
UNASSIGNED: To promote their use, improving pharmacists\' knowledge can help overcome misconceptions about generic drugs and biosimilars. It is recommended that health care stakeholders focus on fostering good understanding among pharmacists to enhance access to medication.

UNASSIGNED: The pan-European BENEFIT study of patients with stable rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who transitioned from reference etanercept to SB4 found no clinically meaningful changes in disease control after transition. The analysis aims to illustrate the peculiarities of the Italian cohort of patients compared with the whole population to provide a more real-life approach to the data for the Italian rheumatologists, ruling out possible local confounding factors.
UNASSIGNED: A prospective study for up to 6 months following transition was conducted. Outcome measures of interest include clinical characteristics at time of transition and disease activity scores (Disease Activity Score-28 [DAS28] for RA, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] for axSpA) over time and safety.
UNASSIGNED: One-hundred and eleven subjects (out of the 557 in total enrolled in the study) were derived from 8 Italian sites, including 79 with RA and 32 with axSpA. In both cohorts, the efficacy was maintained at 3 months and 6 months from the transition to the biosimilar with no significant change in mean DAS28 and BASDAI scores: at the end of the 6 months of observation the mean DAS28 and BASDAI was similar to baseline (confidence interval [CI] -0.22, 0.22), while the mean variation of the BASDAI was -0.14. Of note, 100.0% (95% CI 89.1, 100.0) in the axSpA and 90.8% (95% CI 81.5, 95.5) in the RA cohort of patients continued to receive SB4 at month 6 (binary variable with 95% Clopper-Pearson CI).
UNASSIGNED: Italian patients with stable RA or axSpA who transitioned from originator Etanercept to SB4 maintained clinical response at 6 months post-transition. Both the cohorts are representative of typical patients with long-standing established diagnoses. Most of the patients transitioned to the same dose regimen of biosimilar as that received for the originator, and the regimen remained unchanged at 6 months, supporting the effectiveness of the transition.

To explore whether family-centered communication impacts decisions and optimizes patient-companion-provider consultations.
A parallel, two-arm randomized controlled trial was conducted with 108 participants acting as patients with inflammatory arthritis or companions. Pairs attended a mock consultation where a physician explained the change from a bio-originator to a biosimilar using family-centered or patient-only communication. Participants reported their willingness to transition, risk perceptions, understanding and social support, and completed various scales including the Patient Perception Scale. Interviews helped understand perceptions towards the consultation.
Family-centered communication did not impact willingness to change or cognitive risk perceptions compared to patient-only communication. However, it improved emotional risk perceptions (p = 0.047, Cohen\'s d=.55) and satisfaction with communication (p = 0.015, Cohen\'s d=.71). Feeling the explanation was reassuring was associated with less worry (p = 0.004). Receiving emotional support (p = 0.014) and companions asking fewer questions (p = 0.046) were associated with higher recall. The intervention improved companion involvement (p < 0.001, Cohen\'s d= 1.23) and support (p = 0.002, Cohen\'s d=.86). Interviews showed that encouraging questions, inclusive body language, and acknowledging companions facilitated involvement.
Family-centered communication augments patient-companion-provider encounters but does not influence willingness to change treatment.
Practitioners can use family-centered communication when discussing biosimilars but should provide reassurance, encourage emotional support, and summarize key points to improve understanding.

UNASSIGNED: Biosimilars can improve patient access to biological medicines. Although biosimilars have been shown to be equally effective and safe, some patients remain reluctant to transition to biosimilars. Pharmacists may support patients changing to biosimilars and are often at the frontline for dealing with queries and concerns, but their confidence and readiness for this role are unclear.
UNASSIGNED: This study examines pharmacists\' confidence in explaining biosimilars to patients and explores the information they would provide in response to common queries.
UNASSIGNED: Practicing community, hospital, and primary care pharmacists (N = 142) in New Zealand completed an Internet-based survey on their experience and familiarity with bio-originators and biosimilars, attitudes and concerns towards biosimilars, confidence in explaining key concepts, and responses to common queries. A hierarchical linear regression was conducted to examine possible factors associated with confidence in explaining biosimilars, and a content synthesis was conducted to examine responses to common patient queries.
UNASSIGNED: Pharmacists were most confident in explaining how biosimilars are administered, their efficacy, and cost-saving, and least confident in describing manufacturing and testing. Respondents who had more positive attitudes (B = 1.64, p < .001) and more familiarity with biosimilars (B = 27.15, p < .001) were more confident in educating patients. Pharmacists\' main concerns about biosimilars included reduced efficacy, safety, and a lack of knowledge and acceptance. Responses to common queries were diverse but further highlighted several gaps in knowledge. Gaps included being unable to define biosimilars, provide information on side effects, and believing that biosimilars undergo the same testing process as bio-originators. Pharmacists wanted resources (written and Internet-based) to improve their knowledge and ability to educate patients.
UNASSIGNED: Pharmacists reported a lack of knowledge and confidence in explaining manufacturing processes and testing of biosimilars. Additional resources are needed to support their practice and may help improve patient and companion acceptance of biosimilars.