Catalog No.	C011P
Product Name	Infliximab Biosimilar, Anti-human TNF alpha Antibody | C011P
Supplier Name	Syd Labs, Inc.
Brand Name	Syd Labs
Synonyms	Anti-TNF alpha Chimeric Monoclonal Antibody
Summary	Recombinant Chimeric IgG1 Monoclonal Antibody.
Source/Host	The monoclonal antibody Infliximab biosimilar was produced in the Infliximab biosimilar CHO stable cell line.
Specificity/Sensitivity	The monoclonal antibody Infliximab biosimilar specifically binds to the human TNF alpha.
Applications	ELISA, neutralization, functional assays such as bioanalytical PK and ADA assays, and those assays for studying biological pathways affected by Infliximab.
Form Of Antibody	0.2 uM filtered solution, pH 7.2, no stabilizers or preservatives.
Endotoxin	< 1 EU per 1 mg of the protein by the LAL method.
Purity	>95% by SDS-PAGE under reducing conditions and HPLC.
Shipping	The monoclonal antibody Infliximab biosimilar is shipped with ice pack. Upon receipt, store it immediately at the temperature recommended below.
Stability & Storage	Use a manual defrost freezer and avoid repeated freeze-thaw cycles. 12 months from date of receipt, -20 to -70°C as supplied. 1 month from date of receipt, 2 to 8°C as supplied.
Note	Infliximab biosimilar CHO stable cell line is available for licensing to manufacture the Infliximab biosimilar protein. The research grade infliximab biosimilar protein is for research use only (RUO). Recombinant human IgG1 isotype controls are available.
Order Offline	Phone: 1-617-401-8149 Fax: 1-617-606-5022 Email: message@sydlabs.com Orleave a message with a formal purchase order (PO) Or credit card.

Description

C011P: Infliximab Biosimilar, TNF alpha Monoclonal Antibody

Infliximab, a chimeric anti-TNF-α monoclonal antibody, is used to treat psoriasis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. Infliximab interferes TNF-α from binding to its receptor in the cell.

Mainly produced by activated macrophages (M1), Tumor necrosis factor (TNF, cachexin, cachectin, tumor necrosis factor alpha, TNFα) plays important roles in the regulation of autoimmune reaction.

References for Infliximab Biosimilar:

1、Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching
Hillel P Cohen,et al.BioDrugs. 2024.PMCID: PMC11055790
“As of 31 December, 2023, 31 observational studies have been published, including a total of 6081 patients who underwent a switch from one biosimilar to another biosimilar of the same reference biologic. Most studies evaluated infliximab, while a smaller number evaluated adalimumab, rituximab or etanercept. Indications studied now include sarcoidosis, as well as the indications previously reported of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis/ankylosing spondylitis and inflammatory bowel disease (Crohn’s disease and ulcerative colitis). This updated data set includes eight additional studies and 2386 more patients compared with those included in an earlier systematic review of biosimilar-to-biosimilar switching. In addition, since the earlier systematic review was published in 2022, the European Medicines Agency has stated that reference-to-biosimilar and biosimilar-to-biosimilar switching in the European Union is safe and efficacy remains unchanged after switching. Furthermore, following a review of the available evidence, the US Food and Drug Administration has confirmed that initial safety and immunogenicity concerns related to biosimilar switching are unfounded and that no differences are observed in efficacy, safety or immunogenicity following one or more switches. The availability of this new efficacy and safety data together with the supportive statements from the European Medicines Agency and the Food and Drug Administration re-confirm the conclusion that as a scientific matter, biosimilar-to-biosimilar switching is an effective clinical practice, with no new safety concerns. Any suggestions to the contrary are not supported by the evidence.”

2、A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales – A Mixed Methods Study
Evelien Moorkens,et al.BioDrugs. 2020.PMCID: PMC7803694
“Background
Regions within England, Scotland and Wales show variation in rate of adoption of biosimilar infliximab and etanercept.
Objectives
This study aims to examine how local decisions and practices in regions within England, Scotland and Wales might explain initial variation in market dynamics of biosimilar and originator infliximab and etanercept.
Methods
Market data provided by the National Health Service (NHS) on biosimilar and originator infliximab and etanercept uptake were analysed for the 10 historical regions of England, 14 health boards in Scotland and 7 health boards in Wales (2015–2018). Findings were discussed in ten semi-structured interviews: on a national level with an industry representative (1), on a regional level with NHS employees in England (6), Scotland (1) and Wales (1), and on a local level with a representative of a clinical commissioning group in England (1).
Results
Tenders for infliximab and etanercept in England, Scotland and Wales have consistently resulted in a biosimilar as the best value biological. Early and late biosimilar adopters are seen, with overall convergence towards high biosimilar market shares over time. Qualitative results suggest that biosimilar adoption was positively influenced by (a) a price difference between biosimilar and originator product making it worthwhile to switch patients; (b) a good relationship between commissioner and provider in England resulting in gain share agreements; (c) leadership on biosimilars in regional NHS offices in England or Scottish and Welsh health boards; (d) key opinion leaders or leading hospitals that start using biosimilars early and gain experience.
Conclusions
This study has shown that the savings potential drives biosimilar use. Regions with a proactive attitude, good stakeholder relationships, and clinician engagement were identified as early adopters.”

3、Different Policy Measures and Practices between Swedish Counties Influence Market Dynamics: Part 1—Biosimilar and Originator Infliximab in the Hospital Setting
Evelien Moorkens,et al.BioDrugs. 2019.PMCID: PMC6533410
“Background
Decentralisation of healthcare budgets and issuance of local guidelines means that the use of biosimilars can vary by region within a particular country, for example between the 21 counties of Sweden.
Objectives
This study aimed to analyse the county-level market dynamics of biosimilar and originator infliximab, which are hospital products, and to examine how local policy measures and practices, in addition to national policy, influenced market dynamics.
Methods
We first conducted a literature review on (biosimilar) policies in Sweden, then analysed market data provided by IQVIA™ on uptake of originator and biosimilar infliximab within the different counties (Q2 2012 to Q4 2017), including discounts from (tender) contracts. Biosimilar market shares were calculated with volume data (measured as defined daily doses [DDDs]). We then discussed our findings in semi-structured interviews with the national pricing and reimbursement agency, key experts within the county councils of Skåne, Västra Götaland, and Stockholm, and an industry representative.
Results
Market shares of biosimilar infliximab vary widely between counties (range 18–96% in 2017). The initial uptake of biosimilar infliximab was slow and variable, with abrupt increments in biosimilar market shares coinciding with expiration of contracts for the originator product. Different approaches taken by counties to achieve a low cost per DDD of infliximab were identified, i.e., a rapid switch to the biosimilar (Skåne), a delayed switch to the biosimilar (Stockholm), or no switch to the biosimilar when a favourable price on the originator product could be obtained (Västra Götaland). Quantitative analysis showed that 59% of the variability in biosimilar market shares could be explained by the relative difference in discounted price between the biosimilar and the originator product. In addition, qualitative analysis indicated the presence of key opinion leaders, local guidelines and initiatives, and whose budget it affects as drivers in the decision-making process.
Conclusions
Variations in the market share of biosimilar infliximab between the Swedish counties is largely explained by the discounted price difference between biosimilar and originator product, and counties used different strategies to leverage such biosimilar competition. Additionally, the presence of key opinion leaders, local guidelines and gainsharing arrangements appeared to play a role in infliximab market dynamics in counties.”

4、Physician, Practice, and Patient Characteristics Associated With Biosimilar Use in Medicare Recipients
Emma Boswell Dean,et al.JAMA Netw Open. 2021.PMCID: PMC7841457
“The final filgrastim sample included 25 870 patients (11 857 [45.8%] men; 14 224 [55.0%] aged 65-74 years; 22 617 [87.4%] White individuals) who had 259 178 administrations (79 017 [30.5%] biosimilar administrations), and the final infliximab sample included 14 786 patients (4765 [32.2%] men; 8773 [59.3%] aged 65-74 years; 13 467 [91.1%] White individuals) who had 174 973 administrations (9012 [5.2%] biosimilar administrations). In adjusted analyses, no patient demographic characteristics and 2 of 9 clinical indications (22.2%) were associated with biosimilar use (filgrastim, neutropenia: adjusted difference, −2.0 [95% CI, −3.9 to −0.2] percentage points; P = .03; infliximab, Crohn disease: adjusted difference, −1.8 [95% CI, −2.9 to −0.8] percentage points; P = .001). Several physician characteristics were associated with biosimilar administrations, including high filgrastim or infliximab prescribing volume (high vs low volume, filgrastim: adjusted difference, 3.6 [95% CI, 1.5 to 5.8] percentage points; P = .001; infliximab: adjusted difference, 1.2 [95% CI, 0.3 to 2.2] percentage points; P = .007) and specialty (eg, hematologist-oncologists vs primary care, filgrastim: adjusted difference, −3.0 [95% CI, −5.4 to −0.5] percentage points; P = .02). Numerous practice characteristics were associated with biosimilar use, including practice setting (outpatient hospital department vs office practice, filgrastim: adjusted difference, −16.1 [95% CI, −18.1 to −14.1] percentage points; P < .001; infliximab: adjusted difference, 3.0 [95% CI, 2.2 to 3.7] percentage points; P < .001) and hospital outpatient department ownership status (for-profit vs not-for-profit, filgrastim: adjusted difference, −17.4 [95% CI, −21.6 to −13.3] percentage points; P < .001; infliximab: adjusted difference, 10.8 [95% CI, 6.7 to 14.9] percentage points; P < .001).”

5、Impact of Introducing Infliximab Biosimilars on Total Infliximab Consumption and Originator Infliximab Prices in Eight Regions: An Interrupted Time-Series Analysis
Kuan Peng,et al.BioDrugs. 2023.PMCID: PMC10195719
“Objective
We aimed to assess whether the introduction of the first infliximab biosimilar was associated with changes in overall infliximab consumption (originator and biosimilars) and price changes to the originator infliximab.
Methods
An interrupted time series analysis using infliximab sales data from 2010 to 2020 from the IQVIA Multinational Integrated Data Analysis System for eight selected regions: Australia, Canada, Hong Kong, Korea, India, Japan, the UK, and the USA. Quarterly measures of infliximab consumption and list prices were respectively defined as the number of standard units (SU)/1000 inhabitants and as 2020 USA dollars (USD)/SU.
Results
Following the introduction of infliximab biosimilars, overall infliximab consumption increased in Australia [immediate change: 0.145 SU/1000 inhabitants (P = 0.014); long-term change: 0.022 SU/1000 inhabitants per quarter (P < 0.001)], Canada [immediate change 0.415 (P = 0.008)], the UK [long-term change 0.024 (P < 0.001)], and Hong Kong [immediate change: 0.042 (P < 0.001)]. The list price of originator infliximab also decreased following biosimilar introduction in Australia [immediate change: − 187.84 USD/SU (P < 0.001); long-term change − 6.46 USD/SU per quarter (P = 0.043)], Canada [immediate change: − 145.58 (P < 0.001)], the UK [immediate change: − 34.95 (P = 0.010); long-term change: − 4.77 (P < 0.001)], and Hong Kong [long-term change: − 4.065 (P = 0.046)]. Consumption and price changes were inconsistent in India, Japan, Korea, and the USA.
Conclusions
Introduction of the first infliximab biosimilar was not consistently associated with increased consumption across regions. Additional policy and healthcare system interventions to support biosimilar infliximab adoption are needed.
Supplementary Information
The online version contains supplementary material available at 10.1007/s40259-023-00589-3.”

6、Infliximab for maintenance of medically‐induced remission in Crohn’s disease
Morris Gordon,et al.Cochrane Database Syst Rev. 2024.PMCID: PMC10875719
“Background
Infliximab is a monoclonal antibody that binds and neutralises tumour necrosis factor‐alpha (TNF‐α) which is present in high levels in the blood serum, mucosa and stool of patients with Crohn’s disease.
Objectives
To determine the efficacy and safety of infliximab for maintaining remission in patients with Crohn’s disease.
Search methods
On 31 August, 2021 and 23 June, 2023, we searched CENTRAL, Embase, MEDLINE, ClinicalTrials.gov, and WHO ICTRP.
Selection criteria
Randomised controlled trials (RCTs) in which infliximab was compared to placebo or another active comparator for maintenance, remission, or response in patients with Crohn’s disease.
Data collection and analysis
Pairs of review authors independently selected studies and conducted data extraction and risk of bias assessment. We expressed outcomes as risk ratios and mean differences with 95% confidence intervals. We assessed the certainty of the evidence using GRADE.
Our primary outcome was clinical relapse. Secondary outcomes were loss of clinical response, endoscopic relapse, and withdrawal due to serious and adverse events.
Main results
Nine RCTs with 1257 participants were included. They were conducted between 1999 and 2022; seven RCTs included biologically‐naive patients, and the remaining two included a mix of naive/not naive patients. Three studies included patients in clinical remission, five included patients with a mix of activity scores, and one study included biologic responders with active disease at baseline. All studies allowed some form of concomitant medication during their duration. One study exclusively included patients with fistulating disease. The age of the participants ranged from 18 to 69 years old.”

7、TNF-alpha inhibitors biosimilar use in France: a nationwide population-based study using the French National Health Data System
Hugo Jourdain,et al.Sci Rep. 2022.PMCID: PMC9666557
“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.”

8、Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019
Angela Liu,et al.J Manag Care Spec Pharm. 2023.PMCID: PMC10775772
“BACKGROUND:
Medicare Advantage (MA) and Traditional Medicare face different financing structures and incentives and may implement different strategies to encourage biosimilar uptake. Strategies used by health insurers can influence biosimilar uptake, which can in turn promote savings to insurers and patients.
OBJECTIVE:
To compare filgrastim and infliximab biosimilar uptake between MA and Traditional Medicare from 2016 to 2019 and examine biosimilar uptake by different MA carriers and plan types (Health Maintenance Organization [HMO] or Preferred Provider Organization).
METHODS:
We use a 2016-2019 nationally representative random 20% sample of the carrier (physician) and outpatient paid claims for Traditional Medicare data and final-action carrier and outpatient records for MA data. We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis).
RESULTS:
From their introduction, there was consistently greater uptake of filgrastim and infliximab biosimilars in MA compared with Traditional Medicare. By Q4 2019, filgrastim biosimilar uptake was 7.6 percentage points higher in MA (80.3%) than Traditional Medicare (72.7%). By Q4 2019, infliximab biosimilar uptake was 28.7% and 15.4% in MA and Traditional Medicare, respectively. Kaiser HMO plans were primarily responsible for the higher uptake of biosimilars in MA; in Q4 2019, filgrastim and infliximab biosimilar uptake was 98.8% and 78.8%, respectively.
CONCLUSIONS:
Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs.”

9、Discontinuation and Switchback After Non-Medical Switching from Originator Tumor Necrosis Factor Alpha (TNF) Inhibitors to Biosimilars: A Meta-Analysis of Real-World Studies from 2012 to 2018
Yifei Liu,et al.Adv Ther. 2022.PMCID: PMC9309144
“Introduction
To examine the prevalence rates of biosimilar discontinuation and switchback to the originator tumor necrosis factor alpha (TNF) inhibitors following non-medical switch (NMS) in patients.
Methods
Real-world studies reporting biosimilar discontinuation and switchback rates following NMS published between January 2012 and August 2018 were identified through a systematic literature review. A meta-analysis estimated the annualized discontinuation and switchback rates. A subsequent meta-analysis assessed annualized incremental discontinuation rate among studies reporting both discontinuation rates in patients who underwent an NMS (switchers) and patients who remained on originators (non-switchers).
Results
A total of 66 publications were identified: 31 in gastroenterology, 32 in rheumatology, and 3 in both. Half of the studies reported switchback rates; only 9 studies reported discontinuation rates for both switchers and non-switchers. Across studies, the mean/range sample size of the NMS patient population was 136/9–1641; mean/range follow-up was 10/3–24 months. Annualized biosimilar discontinuation rate was 21% (95% confidence interval [CI] 18%, 25%). Switchback rate was 14% (95% CI 10%, 17%) among all NMS patients and 62% (95% CI 44%, 80%) among discontinuers. The mean/range sample size of switchers and non-switchers was 344/89–1621 and 768/19–2870, respectively; mean/range follow-up was 11/6–18 and 12/6–8 months, respectively. Annualized incremental biosimilar discontinuation rate was 18% (95% CI 4%, 31%).
Conclusion
Biosimilar discontinuation was found to be prevalent among patients who underwent an NMS from an originator TNF inhibitor to its biosimilar(s) in the real world. In addition, switchback to the originator TNF inhibitors was common following biosimilar discontinuation. Careful consideration is necessary when switching patients already on an originator TNF inhibitor to its biosimilar(s). Main limitations included the heterogeneity of the studies and the limited comparability of the data.
Supplementary Information
The online version contains supplementary material available at 10.1007/s12325-022-02173-7.”

10、Patients Retransitioning from Biosimilar TNFα Inhibitor to the Corresponding Originator After Initial Transitioning to the Biosimilar: A Systematic Review
Rosanne W Meijboom,et al.BioDrugs. 2021.PMCID: PMC8847209
“Background
Transitioning patients from an originator to a corresponding biosimilar has been extensively studied in both randomized controlled trials and observational studies. Although transitioning is considered well-tolerated, with no negative impacts on efficacy and/or safety, 2.6–25.8% of patients restart treatment with the originator (retransitioning). Retransitioning to the originator can be considered an indication of biosimilar treatment failure or dissatisfaction with biosimilar treatment. Increasing our knowledge of patients who retransition might help to reduce the number of patients retransitioning.
Objective
Our objective was to estimate the cumulative incidence of patients who retransitioned from a tumor necrosis factor (TNF)-α inhibitor biosimilar to originator and to explore potential patient, disease, and treatment and implementation strategy factors associated with retransitioning.
Method
We conducted a systematic literature search in the PubMed, EMBASE, and Cochrane Central Register of controlled trials databases until March 2021. Studies on TNFα inhibitors, biosimilar transitioning, and retransitioning were included. Transitioning was defined as switching from an originator to a biosimilar, and retransitioning was defined as switching from an originator to a biosimilar and back to the originator. Characteristics of the studies were descriptively analyzed. Studies were weighted by the number of patients transitioning, and the primary outcome was the median cumulative incidence of retransitioning. For each of the factors related to patient, disease, and treatment and implementation strategy, studies were stratified according to the categories of that factor. The weighted medians and interquartile ranges (IQRs) of the cumulative incidence of retransitioning in these studies were calculated and compared to explore whether a potential association existed between these factors and the cumulative incidence of retransitioning.
Results
Of 994 screened publications, 37 were included. The weighted median cumulative incidence of retransitioning was 7.6% (IQR 6.8–17.2). Studies that included only patients with inflammatory bowel disease (6.6 vs. 15.1–17.7% for other indications), included only patients with stable disease (7.0 vs. 13.7% for including all patients), and did not offer retransitioning at the introduction of the biosimilar (7.0 vs. 11.1% for studies that offered retransitioning) reported less retransitioning. In addition, the incidence of retransitioning was lower when extra laboratory monitoring was part of the implementation strategy (1.6 vs. 6.1%) and when gainsharing (patients’ healthcare directly benefits from financial savings from transitioning) (1.4 vs. 7.2% for studies without gainsharing) was applied.
Conclusions
In studies on transitioning patients from TNFα originator to biosimilar, 8% of patients retransitioned. Retransitioning appeared to be lower in studies that included only patients with stable disease and in studies that did not offer patients the option of retransitioning at the introduction of the biosimilar. In addition, retransitioning appeared to be lower in studies that implemented extra laboratory monitoring as part of the biosimilar implementation strategy. Clinicians should consider implementing these suggestions as they might reduce retransitioning rates and improve the introduction of biosimilars in clinical practice.”

Syd Labs also provides the following anti-TNF antibody biosimilar protein:
Adalimumab Biosimilar, research grade

Syd Labs also provides the following research grade antibody biosimilar proteins:
Bevacizumab Biosimilar, research grade (VEGF-A)
Ranibizumab Biosimilar, research grade (VEGF-A, Fab produced in E. coli)
Cetuximab Biosimilar, research grade (HER1, ErbB-1, EGFR)
Panitumumab Biosimilar, research grade (HER1, ErbB-1, EGFR)
Trastuzumab Biosimilar, research grade (HER2, ErbB-2, c-neu)
Pertuzumab Biosimilar, research grade (HER2, ErbB-2, c-neu)
Infliximab biosimilar, research grade (TNF alpha)
Adalimumab biosimilar, research grade (TNF alpha)
Rituximab biosimilar, research grade (CD20)
Denosumab biosimilar, research grade (RANKL, RANK ligand, OPGL, TNFSF11, CD254, TRANCE, ODF)
Palivizumab Biosimilar, research grade (RSV)
Omalizumab biosimilar, research grade (IgE)
Eculizumab biosimilar, research grade (C5)

 

Infliximab Biosimilar from: Infliximab Biosimilar, TNF alpha Monoclonal Antibody: C011P Syd Labs

No more offers for this product!