Adalimumab Biosimilar, Human TNF alpha Antibody | C003P

Catalog No.	C003P
Product Name	Adalimumab Biosimilar, Human TNF alpha Antibody | C003P
Supplier Name	Syd Labs, Inc.
Brand Name	Syd Labs
Synonyms	Anti-TNF alpha Human Monoclonal Antibody
Summary	Recombinant Humanized IgG1 Monoclonal Antibody.
Source/Host	The monoclonal antibody adalimumab biosimilar was produced in the adalimumab biosimilar CHO stable cell line.
Specificity/Sensitivity	The monoclonal antibody adalimumab 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 adalimumab.
Form Of Antibody	0.2 uM filtered solution, pH 5.2, 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 adalimumab 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	Adalimumab biosimilar CHO stable cell line is available for licensing to manufacture the adalimumab biosimilar protein.The research grade adalimumab 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 Or leave a message with a formal purchase order (PO) Or credit card.

Description

C003P: Adalimumab Biosimilar, TNF alpha Monoclonal Antibody

Adalimumab, the first fully human monoclonal antibody drug approved by FDA, binds to TNFα, inactivates TNF receptors, and downregulates the inflammatory reactions associated with a variety of autoimmune diseases, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, moderate to severe chronic psoriasis and juvenile idiopathic arthritis.

Mainly produced by activated macrophages (M1), Tumor necrosis factor (TNF, cachexin, cachectin, tumor necrosis factor alpha, TNFα) plays important roles in the regulation of immune cells. As a member of a group of cytokines that stimulate the acute phase reaction, TNF is involved in systemic inflammation and able to induce fever, apoptotic cell death, cachexia, inflammation, and to inhibit tumorigenesis and viral replication and respond to sepsis via IL1 & IL6 producing cells. Dysregulation of TNF expression could have serious impact in a variety of human diseases including Alzheimer’s disease, cancer, major depression and inflammatory bowel disease.

References for Adalimumab Biosimilar:

1、Budget impact analysis of including biosimilar adalimumab on formulary: A United States payer perspective
Stephen Chaplin,et al.J Manag Care Spec Pharm. 2024.PMCID: PMC11522441
“BACKGROUND:
The biosimilar market is growing rapidly, as evidenced by 41 approvals and 37 launches to date. As adalimumab biosimilars launch in the United States, competition among biosimilar and reference adalimumab will likely increase across multiple reference indications, including rheumatology, dermatology, and gastrointestinal diseases, which may lead to decreased payer costs.
OBJECTIVE:
To evaluate the costs of adding biosimilar adalimumab to a US commercial plan by exploring various utilization and price differential scenarios.
METHODS:
A 3-year budget impact model for a US commercial plan of 1 million people was developed to assess switching from reference adalimumab or any self-injectable reference tumor necrosis factor (TNF) inhibitor to biosimilar adalimumab. Pharmacy and medical costs were analyzed through high- and low-conversion scenarios from reference adalimumab and the TNF inhibitor class. Price reductions of 5% to 60% relative to reference adalimumab based on previous biosimilar launches were also explored. Short-term medical costs were evaluated as additional simple and complex office visits, with scenarios of half of switch patients having 1 visit up to all switch patients having 10 visits.
RESULTS:
In a target population of 1,863 patients, switching from reference adalimumab to biosimilar adalimumab had cumulative cost savings of $5,756,073 with slow conversion (10%-20% over 3 years) and $28,780,365 with fast conversion (50%-100% over 3 years). Similar results were seen when switching from any other self-injectable reference TNF inhibitor. Cost savings more than $1 million were seen with a 10% conversion from reference adalimumab and a 15% price reduction from reference adalimumab. Additional office visit scenarios had a negligible impact on budget, with no changes in per-member-per-month costs until all switch patients had 10 additional complex visits, in which per-member-per-month costs increased by $0.02.
CONCLUSIONS:
In a hypothetical plan of 1 million lives, use of biosimilar adalimumab in commercial plans can lead to significant cost savings for payers because of increased competition. Greater and faster biosimilar conversion rates from reference adalimumab and other reference TNF inhibitors resulted in decreased costs. Additionally, even with short-term medical expenditures, cost savings were still realized when switching to biosimilar adalimumab.”

2、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.”

3、Outcomes Following a Mandatory Nonmedical Switch From Adalimumab Originator to Adalimumab Biosimilars in Patients With Psoriasis
Nikolai Loft,et al.JAMA Dermatol. 2021.PMCID: PMC8027941
“Importance
The efficacy of adalimumab biosimilars is similar to that of brand-name adalimumab (Humira, hereinafter originator) in clinical trials. However, limited knowledge about real-world data exists for adalimumab biosimilars.
Objective
To assess the outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis.
Design, Setting, and Participants
This cohort study assesses the outcomes following a switch from adalimumab originator to an adalimumab biosimilar. Patients in the Biological Treatment in Danish Dermatology (DERMBIO) registry, a Danish nationwide registry of all patients treated with biologics (including biosimilars) for psoriasis since 2007, were assessed for eligibility. All patients who switched from adalimumab originator to an adalimumab biosimilar between November 1, 2018, and May 1, 2019, were included in the adalimumab biosimilar cohort. All patients with a visit between May 1, 2017, and November 1, 2017, treated with adalimumab originator were included in the adalimumab originator cohort. Data were analyzed from June 1, 2020, to October 10, 2021.”

4、‘Totality of Evidence’ Approach in the Development of GP2017, an Approved Adalimumab Biosimilar
Norman Gaylis,et al.Adv Ther. 2024.PMCID: PMC11052879
“Introduction
Hyrimoz®, (GP2017 [SDZ-ADL]), is a biosimilar to Humira® (REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL.
Totality of Evidence—the approach
Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation.
Evidence of biosimilarity
Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL’s efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL.
Conclusion
Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.”

5、Is the Availability of Biosimilar Adalimumab Associated with Budget Savings? A Difference-in-Difference Analysis of 14 Countries
Hyunjung Woo,et al.BioDrugs. 2023.PMCID: PMC10789825
“Objective
The aim was to assess the influence of the presence of biosimilar adalimumab on adalimumab budget savings in 14 high- and upper-middle-income countries.
Methods
This study analyzed Multinational Integrated Data Analysis System (MIDAS)-IQVIA data from the fourth quarter (Q4) of 2018 to the Q4 of 2019, comparing adalimumab expenditure (in United States dollars) and consumption (in standard units [SU]) across 14 countries (Australia, Austria, Brazil, Canada, France, Germany, Italy, Japan, Korea, Singapore, South Africa, Spain, Sweden, and Taiwan). The countries were divided into two groups based on the availability of adalimumab biosimilars during the study period. A difference-in-difference design was employed to analyze the groups, focusing on changes from Q4 2018 to Q4 2019. Additionally, changes in adalimumab expenditure were decomposed into price, quantity, and drug mix during the study period.
Results
Among countries with adalimumab biosimilars, there was a significant decrease in expenditure (− $371.0 per gross domestic product per capita; p = 0.03) over four quarters, while the consumption significantly increased (1.0 SU per 1000 population; p = 0.02). This was consistent with visual observations and differed from countries without adalimumab biosimilar. Sensitivity analysis with a narrowed list of countries (12 high-income countries) showed a consistent trend. Adalimumab expenditure decreased by 14% during the study period in countries where adalimumab biosimilars were available, mainly due to the price changes (Pt = 0.85; − 15%) and the drug-mix effect (εt = 0.88; − 12%). Yet, adalimumab expenditure (Et = 1.04; +4%) changed in a quantity-dependent manner (Qt = 1.06; +6%) in countries where adalimumab biosimilars were absent.
Conclusion
The availability of biosimilars was associated with a decrease in adalimumab expenditure without compromising the consumption of adalimumab.”

6、Cost-Effectiveness of Biosimilars vs Leflunomide in Patients With Rheumatoid Arthritis
Kuan Peng,et al.JAMA Netw Open. 2024.PMCID: PMC11208978
“Importance
Among patients with rheumatoid arthritis (RA) who had an inadequate response to methotrexate, a treatment sequence initiated with biosimilar disease-modifying antirheumatic drugs (DMARDs) provides better clinical efficacy compared with conventional synthetic DMARDs recommended by current treatment guidelines; but its cost-effectiveness evidence remains unclear.
Objective
To evaluate the cost-effectiveness of the treatment sequence initiated with biosimilar DMARDs after failure with methotrexate vs leflunomide and inform formulary listing decisions.
Design, Setting, and Participants
This economic evaluation’s cost-effectiveness analysis was performed at a Hong Kong public institution using the Markov disease transition model to simulate the lifetime disease progression and cost for patients with RA, using monetary value in 2022. Scenario and sensitivity analyses were performed to test the internal validity of the modeling conclusion. Participants included patients diagnosed with RA from 2000 to 2021 who were retrieved retrospectively from local electronic medical records to generate model input parameters. Statistical analysis was performed from January 2023 to March 2024.
Interventions
The model assesses 3 competing treatment sequences initiated with biosimilar infliximab (CT-P13), biosimilar adalimumab (ABP-501), and leflunomide; all used in combination with methotrexate.”

7、Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review
Jessica R Allegretti,et al.Adv Ther. 2024.PMCID: PMC11052875
“Adalimumab (ADL, Humira®, reference product), an anti-TNF-α biologic, has transformed the treatment of chronic, immune-mediated inflammatory diseases. However, the high cost of ADL therapy has driven the development of more affordable ADL biosimilars, agents with no clinically meaningful differences from the reference product. This review summarizes the product attributes of reference ADL and the nine ADL biosimilars approved and available in the USA in relation to patient experience of injection-site pain (ISP). Product formulation, delivery volume and device features (e.g., type and needle gauge size) influence patient experience of ISP with potential clinical consequences. Citrate-free formulations generally cause less ISP; injection volumes of > 1.5 ml may be associated with increased ISP. Reference ADL and all ADL biosimilars offer a citrate-free formulation, and reference ADL and four ADL biosimilars offer a high-concentration solution that allows a smaller injection volume. All available ADL products are injected subcutaneously using either a pre-filled pen (PFP) or pre-filled syringe (PFS). Patients prefer the PFP, but the PFS permits better control over the speed and duration of injection. Smaller (29-gauge) needle outer diameter is associated with less ISP; reference ADL and seven ADL biosimilars offer a device with a 29-gauge needle. In the USA, an approved biosimilar can be designated “interchangeable,” allowing pharmacy-level substitution, where state law permits. In the USA, two ADL biosimilars have received interchangeability designation; others are seeking interchangeability designation from the Food and Drug Administration (n = 2), are being evaluated in clinical studies to support interchangeability (n = 2), or do not have/are not seeking interchangeability designation (n = 3). Product-related attributes influence patient experience of ISP caused by subcutaneous ADL injection. Reference ADL and ADL biosimilar products differ in their attributes, so discussion with patients about treatment options is essential to optimize adherence and outcomes.”

8、Influence of information provided prior to switching from Humira to biosimilar adalimumab on UK patients’ satisfaction: a cross-sectional survey by patient organisations
Kayoko Kaneko,et al.BMJ Open. 2022.PMCID: PMC8852668
“A total of 899 people living with various immune mediated inflammatory diseases participated in this survey. Thirty-four per cent of respondents reported poor overall satisfaction with their biosimilar adalimumab after the switch, associated with complaints related to the switching process including lack of shared decision making, scarcity of information provided by or signposted to by the department instigating the switch as well as lack of training with the new injection device. Where training with the new device had been provided, there were significantly reduced reports of pain when injecting the new biosimilar (OR 0.20, 95% CI 0.07 to 0.55), side effects (OR 0.17, 95% CI 0.06 to 0.47) and difficulty in using the new injection device (OR 0.25, 95% CI 0.15 to 0.41). Self-reported side effects were reduced by (OR 0.13, 95% CI 0.05 to 0.38) when written information was provided by healthcare professionals and by (OR 0.15, 95% CI 0.05 to 0.42) with provision of verbal information. Difficulty in using the new injection device was also reduced by provision of satisfactory information such as written documents (OR 0.38, 95% CI 0.23 to 0.63) or by verbal communication with healthcare professionals (OR 0.45, 95% CI 0.27 to 0.73). Finally, provision of satisfactory written or verbal information was associated with a reduction in any negative perception regarding symptom control with the new biosimilar by (OR 0.05, 95% CI 0.004 to 0.57) and by (OR 0.15, 95% CI 0.03 to 0.84), respectively.”

9、Real-world experience and long-term outcomes of a mandatory non-medical switch of adalimumab originator to biosimilars in inflammatory bowel disease
Jeremy Liu Chen Kiow,et al.World J Gastroenterol. 2024.PMCID: PMC11612714
“BACKGROUND
Over the last decade, the treatment options for inflammatory bowel disease (IBD) have significantly progressed with the emergence of new medications designed to target various immune pathways and mitigate inflammation. Adalimumab (ADA) is a tumor necrosis factor alpha antagonist and stands as an effective treatment for IBD. In April 2021, the province of British Columbia implemented a mandatory non-medical switch policy of the ADA originator Humira® to ADA biosimilars. Biosimilars offer a potential cost-effective, safe, and efficacious alternative to the originator, yet there remains limited real-world evidence on long-term outcomes of ADA non-medical switching in IBD.
AIM
To assess the long-term outcomes of non-medical switching from the ADA originator Humira® to an ADA biosimilar among IBD patients.
METHODS
A retrospective observational chart review study was conducted on IBD patients eligible for the provincially mandated non-medical switch to an ADA biosimilar. The primary outcome was treatment persistence at 30 months post-switch. Secondary outcomes included the proportion of and reasons for therapy alteration or ADA discontinuation, loss of response (LOR) rates, adverse events (AE), and clinical and biochemical remission status. Patients who remained on the originator throughout the switch period, through compassionate support or private pay, constituted the comparison group.
RESULTS
Patients in the originator (n = 43) and biosimilar switch (n = 228) groups displayed similar demographics and baseline disease characteristics. By the study endpoint of 30 months, there was no difference in the rate of treatment persistence in either group (n = 36, 83.7% originator group vs n = 201, 88.2% biosimilar group, P = 0.451). Treatment persistence demonstrated similar rates of discontinuation between both study groups (log-rank P = 0.543). There was a numerical but not statistically significant difference in rates of adverse outcomes between either group (39.5% originator vs 28.9% biosimilars, P = 0.206). This included comparable rates of LOR (27.9% vs 17.5%) or AE (11.6% vs 11.4%) between the originator and biosimilar cohorts, respectively. C-reactive protein and fecal calprotectin levels were similar one year pre- and post-switch.
CONCLUSION
These data support the long-term efficacy and safety of non-medical ADA switching in IBD and will help inform patients and physicians in jurisdictions currently undergoing biosimilar switching.”

10、Review of Adalimumab Biosimilar SB5 in Immune-Mediated Inflammatory Diseases
Jonathan Kay,et al.Adv Ther. 2023.PMCID: PMC10838831
“SB5 is an approved biosimilar of adalimumab, a recombinant monoclonal anti-tumor necrosis factor (TNF) antibody. The approval of SB5 was based on the comparison with reference adalimumab in analytical studies, pharmacokinetic (PK) and immunogenicity assessments, and randomized controlled trials. Efficacy data was primarily obtained in patients with rheumatoid arthritis, and extended to include additional indications such as psoriasis, Crohn’s disease, or ulcerative colitis by extrapolation. Following its approval, additional post-marketing data have been collected comparing SB5 with reference adalimumab. This review summarizes the clinical data on SB5 from randomized controlled trials and provides a comprehensive overview of the available post-approval data. In “real-world” settings, SB5 was as effective as its reference product across different indications and countries, treatment persistence was well maintained throughout studies, and no new safety concerns were identified. In both controlled and “real-world” settings, switching from reference adalimumab to SB5 was not associated with altered efficacy or clinical complications. In post-approval studies, the quality of SB5 was consistent over time, independent of the batch and process changes, and the SB5 autoinjector was preferred over other autoinjectors by both healthcare professionals and patients. Taken together, these data support the use of SB5 whenever reference adalimumab is appropriate and demonstrate that switching from reference adalimumab to SB5 is feasible.”

Syd Labs also provides the following anti-TNF antibody biosimilar protein:
Infliximab 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)

Adalimumab Biosimilar from: Adalimumab Biosimilar, TNF alpha Monoclonal Antibody: C003P Syd Labs

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