Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies [Draft]

Biotechnology Law ReportVol. 30, No. 2 DocumentsGuideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies [Draft]Published Online:14 Apr 2011https://doi.org/10.1089/blr.2011.9970AboutSectionsView articleView Full TextPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byThe Rise of Anti-TNF Biosimilars: Guidelines, Real-World Evidence, and Challenges to Acceptance4 November 2022 | EMJ GastroenterologyReal-world effectiveness and persistence of reference etanercept versus biosimilar etanercept GP2015 among rheumatoid arthritis patients: A cohort study3 October 2022 | Frontiers in Pharmacology, Vol. 13Monoclonal Antibodies for Cancer Treatment8 June 2022A randomized, double-blind, single-dose, two-way, parallel phase I clinical study comparing the pharmacokinetics and safety of adalimumab injecta and Humira® in healthy Chinese male volunteers30 June 2021 | Expert Opinion on Biological Therapy, Vol. 22, No. 2Analytical similarity assessment of MYL-1402O to reference Bevacizumab13 October 2021 | Expert Opinion on Biological Therapy, Vol. 22, No. 2Comparative biosimilar quality studies between a rituximab product and MabTheraJournal Of Advanced Pharmacy Education And Research, Vol. 11, No. 4Physicochemical analysis and biological characterization of FKB327 as a biosimilar to adalimumab4 June 2020 | Pharmacology Research & Perspectives, Vol. 8, No. 3Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single‐Blind, Single‐Dose, Parallel‐Group Study in Healthy Subjects19 October 2019 | Clinical Pharmacology in Drug Development, Vol. 9, No. 2Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma16 January 2019 | Drug Safety, Vol. 42, No. 6The Emerging Treatment Landscape of Inflammatory Bowel Disease: Role of Innovator Biologics and Biosimilars11 December 2018 | EMJ GastroenterologyBiosimilar Law and Regulation: An Essential GuideSSRN Electronic Journal, Vol. 12 Volume 30Issue 2Apr 2011 InformationCopyright 2011, Mary Ann Liebert, Inc.To cite this article:Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies [Draft].Biotechnology Law Report.Apr 2011.235-242.http://doi.org/10.1089/blr.2011.9970Published in Volume: 30 Issue 2: April 14, 2011PDF download