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Page 1
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study.
Hövelmann U, Raiter Y, Chullikana A, Liu M, Donnelly C, Lawrence T, Sengupta N, Cl G, Ranganna G, Barve A. Hövelmann U, et al. Among authors: ranganna g. Diabetes Obes Metab. 2021 Dec;23(12):2670-2678. doi: 10.1111/dom.14519. Epub 2021 Aug 25. Diabetes Obes Metab. 2021. PMID: 34378861 Free PMC article. Clinical Trial.
A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ. Waller CF, et al. Among authors: ranganna gm. J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18. J Cancer Res Clin Oncol. 2018. PMID: 29671069 Clinical Trial.
Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Waller CF, Ranganna GM, Pennella EJ, Blakeley C, Bronchud MH, Mattano LA Jr, Berzoy O, Voitko N, Shparyk Y, Lytvyn I, Rusyn A, Popov V, Láng I, Beckmann K, Sharma R, Baczkowski M, Kothekar M, Barve A. Waller CF, et al. Among authors: ranganna gm. Ann Hematol. 2019 May;98(5):1217-1224. doi: 10.1007/s00277-019-03639-5. Epub 2019 Mar 1. Ann Hematol. 2019. PMID: 30824956 Free PMC article. Clinical Trial.
Phase III double-blind study comparing the efficacy and safety of proposed biosimilar MYL-1402O and reference bevacizumab in stage IV non-small-cell lung cancer.
Socinski MA, Waller CF, Idris T, Bondarenko I, Luft A, Beckmann K, Vishweswaramurthy A, Loganathan S, Donnelly C, Hummel MA, Shapiro R, Woods M, Rao A, Nayak VG, Ranganna G, Barve A. Socinski MA, et al. Among authors: ranganna g. Ther Adv Med Oncol. 2021 Nov 18;13:17588359211045845. doi: 10.1177/17588359211045845. eCollection 2021. Ther Adv Med Oncol. 2021. PMID: 34819997 Free PMC article.
Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Aspart (MYL-1601D) Compared with Originator Insulin Aspart (Novolog®) in Patients with Type 1 Diabetes After 24 Weeks: A Randomized Open-Label Study.
Blevins TC, Raiter Y, Sun B, Donnelly C, Shapiro R, Chullikana A, Rao A, Vashishta L, Ranganna G, Barve A. Blevins TC, et al. Among authors: ranganna g. BioDrugs. 2022 Nov;36(6):761-772. doi: 10.1007/s40259-022-00554-6. Epub 2022 Sep 17. BioDrugs. 2022. PMID: 36114990 Free PMC article. Clinical Trial.
Population Pharmacokinetics of MYL-1402O, a Proposed Biosimilar to Bevacizumab and Reference Product (Avastin®) in Patients with Non-squamous Non-small Cell Lung Cancer.
Owen JS, Rackley RJ, Hummel MA, Roepcke S, Huang H, Liu M, Idris TA, Murugesan SMN, Marwah A, Loganathan S, Ranganna G, Barve A, Waller CF, Socinski MA. Owen JS, et al. Among authors: ranganna g. Eur J Drug Metab Pharmacokinet. 2023 Nov;48(6):675-689. doi: 10.1007/s13318-023-00855-3. Epub 2023 Oct 4. Eur J Drug Metab Pharmacokinet. 2023. PMID: 37792130 Clinical Trial.
The Path Towards a Tailored Clinical Biosimilar Development.
Schiestl M, Ranganna G, Watson K, Jung B, Roth K, Capsius B, Trieb M, Bias P, Maréchal-Jamil J. Schiestl M, et al. Among authors: ranganna g. BioDrugs. 2020 Jun;34(3):297-306. doi: 10.1007/s40259-020-00422-1. BioDrugs. 2020. PMID: 32266678 Free PMC article. Review.