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For: Webster CJ, Wong AC, Woollett GR. An Efficient Development Paradigm for Biosimilars. BioDrugs 2019;33:603-11. [PMID: 31388969 DOI: 10.1007/s40259-019-00371-4] [Cited by in Crossref: 14] [Cited by in F6Publishing: 9] [Article Influence: 7.0] [Reference Citation Analysis]
Number Citing Articles
1 Park JP, Jung B, Park HK, Shin D, Jung JA, Ghil J, Han J, Kim KA, Woollett GR. Interchangeability for Biologics is a Legal Distinction in the USA, Not a Clinical One. BioDrugs 2022. [PMID: 35696067 DOI: 10.1007/s40259-022-00538-6] [Reference Citation Analysis]
2 González CPV, Muñoz CG. The controversy around technical standards for similar biotherapeutics: barriers to access and competition?. Pharmacoepidemiol Drug Saf 2020;29:1518-22. [PMID: 32964695 DOI: 10.1002/pds.5100] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
3 Rojas-Chavarro LF, de Mora F. Extrapolation: Experience gained from original biologics. Drug Discov Today 2021;26:2003-13. [PMID: 34022458 DOI: 10.1016/j.drudis.2021.05.006] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
4 Kurki P, Kang HN, Ekman N, Knezevic I, Weise M, Wolff-Holz E. Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience. BioDrugs 2022. [PMID: 35596890 DOI: 10.1007/s40259-022-00533-x] [Cited by in Crossref: 1] [Article Influence: 1.0] [Reference Citation Analysis]
5 Rahalkar H, Sheppard A, Salek S. Biosimilar development and review process in the BRICS-TM countries: proposal for a standardized model to improve regulatory performance. Expert Rev Clin Pharmacol 2022. [PMID: 35078378 DOI: 10.1080/17512433.2022.2034498] [Cited by in Crossref: 1] [Cited by in F6Publishing: 1] [Article Influence: 1.0] [Reference Citation Analysis]
6 Vulto AG. Delivering on the Promise of Biosimilars. BioDrugs 2019;33:599-602. [PMID: 31606870 DOI: 10.1007/s40259-019-00388-9] [Cited by in Crossref: 4] [Cited by in F6Publishing: 3] [Article Influence: 2.0] [Reference Citation Analysis]
7 Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Gardarsdottir H. Type and Extent of Information on (Potentially Critical) Quality Attributes Described in European Public Assessment Reports for Adalimumab Biosimilars. Pharmaceuticals (Basel) 2021;14:189. [PMID: 33669108 DOI: 10.3390/ph14030189] [Reference Citation Analysis]
8 Wolff-Holz E, Weise M. [Biosimilars in the European Union: current situation and challenges]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2020;63:1365-72. [PMID: 33034693 DOI: 10.1007/s00103-020-03225-5] [Cited by in Crossref: 1] [Article Influence: 0.5] [Reference Citation Analysis]
9 Schiestl M, Ranganna G, Watson K, Jung B, Roth K, Capsius B, Trieb M, Bias P, Maréchal-Jamil J. The Path Towards a Tailored Clinical Biosimilar Development. BioDrugs 2020;34:297-306. [PMID: 32266678 DOI: 10.1007/s40259-020-00422-1] [Cited by in Crossref: 9] [Cited by in F6Publishing: 6] [Article Influence: 9.0] [Reference Citation Analysis]
10 Stebbing J, Mainwaring PN, Curigliano G, Pegram M, Latymer M, Bair AH, Rugo HS. Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars. J Clin Oncol 2020;38:1070-80. [PMID: 32058846 DOI: 10.1200/JCO.19.02953] [Cited by in Crossref: 8] [Cited by in F6Publishing: 3] [Article Influence: 4.0] [Reference Citation Analysis]
11 Arad N, Kroetsch A, McClellan M. Overcoming Barriers to Biosimilar Adoption: Commentary on "Cost to Medicare of Delayed Adalimumab Biosimilar Availability". Clin Pharmacol Ther 2021. [PMID: 34487350 DOI: 10.1002/cpt.2403] [Reference Citation Analysis]
12 Druedahl LC, Kälvemark Sporrong S, van de Weert M, De Bruin ML, Hoogland H, Minssen T, Almarsdóttir AB. Evolving Biosimilar Clinical Requirements: A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators. BioDrugs 2021;35:351-61. [PMID: 33830478 DOI: 10.1007/s40259-021-00478-7] [Reference Citation Analysis]
13 Rahalkar H, Sheppard A, Lopez-Morales CA, Lobo L, Salek S. Challenges Faced by the Biopharmaceutical Industry in the Development and Marketing Authorization of Biosimilar Medicines in BRICS-TM Countries: An Exploratory Study. Pharmaceut Med 2021;35:235-51. [PMID: 34292558 DOI: 10.1007/s40290-021-00395-8] [Cited by in Crossref: 2] [Cited by in F6Publishing: 1] [Article Influence: 2.0] [Reference Citation Analysis]
14 Bielsky M, Cook A, Wallington A, Exley A, Kauser S, Hay JL, Both L, Brown D. Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial. Drug Discovery Today 2020;25:1910-8. [DOI: 10.1016/j.drudis.2020.09.006] [Cited by in Crossref: 9] [Cited by in F6Publishing: 5] [Article Influence: 4.5] [Reference Citation Analysis]
15 Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Gardarsdottir H. Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study. Biologicals 2021;69:30-7. [PMID: 33454195 DOI: 10.1016/j.biologicals.2020.12.003] [Cited by in Crossref: 1] [Article Influence: 1.0] [Reference Citation Analysis]
16 Webster CJ, George KL, Woollett GR. Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance. BioDrugs 2021;35:379-87. [PMID: 34143406 DOI: 10.1007/s40259-021-00488-5] [Reference Citation Analysis]