# Biosimilars and Bioanalytical Methods

**Type:** Topics  
**Canonical URL:** https://scholariq.org/topics/biosimilars-and-bioanalytical-methods/

## Facts

| Field | Value |
| --- | --- |
| Description | This cluster of papers focuses on the immunogenicity of biosimilar therapeutics, including the validation of bioanalytical methods for assessing immunogenicity, the impact of manufacturing changes on immunogenicity, and the clinical outcomes and safety of switching from reference biologics to biosimilars. The use of dried blood spots for bioanalysis and the regulatory considerations for biosimilars are also prominent topics within this cluster. |
| Domain | Life Sciences |
| Field | Immunology and Microbiology |
| OpenAlex ID | t12255 |
| Works | 142 |

## Topic papers all

Showing 15 of 142.

- [EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update](https://scholariq.org/papers/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic/)
- [EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update](https://scholariq.org/papers/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic-2/)
- [Correction of Anemia with Epoetin Alfa in Chronic Kidney Disease](https://scholariq.org/papers/correction-of-anemia-with-epoetin-alfa-in-chronic-kidney-disease/)
- [Anti-TNF Antibody Therapy in Rheumatoid Arthritis and the Risk of Serious Infections and Malignancies](https://scholariq.org/papers/anti-tnf-antibody-therapy-in-rheumatoid-arthritis-and-the-risk-of-serious/)
- [Normalization of Hemoglobin Level in Patients with Chronic Kidney Disease and Anemia](https://scholariq.org/papers/normalization-of-hemoglobin-level-in-patients-with-chronic-kidney-disease-and/)
- [A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease](https://scholariq.org/papers/a-trial-of-darbepoetin-alfa-in-type-2-diabetes-and-chronic-kidney-disease/)
- [Influence of Immunogenicity on the Long-Term Efficacy of Infliximab in Crohn's Disease](https://scholariq.org/papers/influence-of-immunogenicity-on-the-long-term-efficacy-of-infliximab-in-crohn-s/)
- [EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update](https://scholariq.org/papers/eular-recommendations-for-the-management-of-rheumatoid-arthritis-with-synthetic-3/)
- [2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease‐modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis](https://scholariq.org/papers/2012-update-of-the-2008-american-college-of-rheumatology-recommendations-for-the/)
- [History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology](https://scholariq.org/papers/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and/)
- [Comparison of tocilizumab monotherapy versus methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study](https://scholariq.org/papers/comparison-of-tocilizumab-monotherapy-versus-methotrexate-monotherapy-in/)
- [Predictors of anti-TNF treatment failure in anti-TNF-naive patients with active luminal Crohn's disease: a prospective, multicentre, cohort study](https://scholariq.org/papers/predictors-of-anti-tnf-treatment-failure-in-anti-tnf-naive-patients-with-active/)
- [Direct Health Care Costs of Crohn's Disease and Ulcerative Colitis in US Children and Adults](https://scholariq.org/papers/direct-health-care-costs-of-crohn-s-disease-and-ulcerative-colitis-in-us/)
- [Maintenance of Remission Among Patients With Crohn's Disease on Antimetabolite Therapy After Infliximab Therapy Is Stopped](https://scholariq.org/papers/maintenance-of-remission-among-patients-with-crohn-s-disease-on-antimetabolite/)
- [Treatment of Anemia with Darbepoetin Alfa in Systolic Heart Failure](https://scholariq.org/papers/treatment-of-anemia-with-darbepoetin-alfa-in-systolic-heart-failure/)

## Topic primary papers

Showing 15 of 34.

- [History of Erythropoiesis-Stimulating Agents, the Development of Biosimilars, and the Future of Anemia Treatment in Nephrology](https://scholariq.org/papers/history-of-erythropoiesis-stimulating-agents-the-development-of-biosimilars-and/)
- [A Practical Guide to Immunoassay Method Validation](https://scholariq.org/papers/a-practical-guide-to-immunoassay-method-validation/)
- [Policies for biosimilar uptake in Europe: An overview](https://scholariq.org/papers/policies-for-biosimilar-uptake-in-europe-an-overview/)
- [Subjective Complaints as the Main Reason for Biosimilar Discontinuation After Open‐Label Transition From Reference Infliximab to Biosimilar Infliximab](https://scholariq.org/papers/subjective-complaints-as-the-main-reason-for-biosimilar-discontinuation-after/)
- [Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries](https://scholariq.org/papers/budget-impact-analysis-of-biosimilar-infliximab-ct-p13-for-the-treatment-of/)
- [The PROSIT-BIO Cohort](https://scholariq.org/papers/the-prosit-bio-cohort/)
- [The protein science of biosimilars](https://scholariq.org/papers/the-protein-science-of-biosimilars/)
- [Systematic review with meta‐analysis: the efficacy and safety of CT‐P13, a biosimilar of anti‐tumour necrosis factor‐α agent (infliximab), in inflammatory bowel diseases](https://scholariq.org/papers/systematic-review-with-meta-analysis-the-efficacy-and-safety-of-ct-p13-a/)
- [Biosimilars for the management of rheumatoid arthritis: economic considerations](https://scholariq.org/papers/biosimilars-for-the-management-of-rheumatoid-arthritis-economic-considerations/)
- [The Rituximab Biosimilar CT-P10 in Rheumatology and Cancer: A Budget Impact Analysis in 28 European Countries](https://scholariq.org/papers/the-rituximab-biosimilar-ct-p10-in-rheumatology-and-cancer-a-budget-impact/)
- [Incidence of erythropoietin antibody-mediated pure red cell aplasia: the Prospective Immunogenicity Surveillance Registry (PRIMS)](https://scholariq.org/papers/incidence-of-erythropoietin-antibody-mediated-pure-red-cell-aplasia-the/)
- [A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases](https://scholariq.org/papers/a-sex-and-gender-based-analysis-of-adverse-drug-reactions-a-scoping-review-of/)
- [A budget impact model for biosimilar infliximab in Crohn’s disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania, and Slovakia](https://scholariq.org/papers/a-budget-impact-model-for-biosimilar-infliximab-in-crohn-s-disease-in-bulgaria/)
- [The PROSIT Cohort of Infliximab Biosimilar in IBD: A Prolonged Follow-up on the Effectiveness and Safety Across Italy](https://scholariq.org/papers/the-prosit-cohort-of-infliximab-biosimilar-in-ibd-a-prolonged-follow-up-on-the/)
- [Efficacy, safety and pharmacokinetics of biosimilars of anti-tumor necrosis factor-α agents in rheumatic diseases; A systematic review and meta-analysis](https://scholariq.org/papers/efficacy-safety-and-pharmacokinetics-of-biosimilars-of-anti-tumor-necrosis/)

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Source: ScholarIQ — public research metadata, principally OpenAlex. See https://scholariq.org/sources/ for provenance and https://scholariq.org/methodology/ for what these figures mean.