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Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.
Waller, Cornelius F; Ranganna, Gopinath M; Pennella, Eduardo J; Blakeley, Christopher; Bronchud, Miguel H; Mattano, Leonard A; Berzoy, Oleksandr; Voitko, Nataliia; Shparyk, Yaroslav; Lytvyn, Iryna; Rusyn, Andriy; Popov, Vasil; Láng, István; Beckmann, Katrin; Sharma, Rajiv; Baczkowski, Mark; Kothekar, Mudgal; Barve, Abhijit.
Affiliation
  • Waller CF; Department of Haematology, Oncology and Stem Cell Transplantation, University Medical Centre Freiburg and Faculty of Medicine, University of Freiburg, Hugstetter Street 55, 79106, Freiburg, Germany. cornelius.waller@uniklinik-freiburg.de.
  • Ranganna GM; Global Clinical Research & Development, Mylan, Prestige Tech Park Platina-3, 7th to 12th Floor, Kadubesanahalli, Bangalore, 560103, India.
  • Pennella EJ; Global Clinical Research, Mylan, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA.
  • Blakeley C; Medical and Scientific Affairs, Worldwide Clinical Trials, 172 Tottenham Court Road, Fitzrovia, London, W1T 7DL, UK.
  • Bronchud MH; GenesisCare Corachan Institute of Oncology, Buïgas 19, 08017, Barcelona, Spain.
  • Mattano LA; HARP Pharma Consulting, LLC, 184 Masons Island Road, Mystic, CT, 06355, USA.
  • Berzoy O; Mammalogy Center, Odessa Regional Hospital, Akademika Zabolotnogo Str. 26, Odessa, 65025, Ukraine.
  • Voitko N; Chemotherapy II, Kyiv City Clinical Oncological Centre, Kyiv, Street, Verkhovyna, 69, Kiev, 03115, Ukraine.
  • Shparyk Y; Department of Chemotherapy, Lviv State Regional Treatment and Diagnostics Oncology Center, Lviv Street, Pekarskaya, 69, Lviv, 79010, Ukraine.
  • Lytvyn I; Department of Chemotherapy, Dnipropetrovsk Regional Clinical Oncology Center, Kosmicheskaja Street, 21, Dnepropetrovsk, 49100, Ukraine.
  • Rusyn A; Department of Chemotherapy, Transkarpathian Regional University Oncology Clinic, Narodna Square, 3, Uzhgorod, 88000, Ukraine.
  • Popov V; Department of Medical Oncology and Palliative Care, SHATOD Dr. Marko Аntonov Markov, Varna EOOD, SHOP "Tsar Osvoboditel" Boulevard 100000, 9000, Varna, Bulgaria.
  • Láng I; Department of Medical Oncology and Clinical Pharmacology B, National Institute of Oncology Országos Onkológiai Intézet, Budapest Ráth György u. 7-9, Budapest, 1122, Hungary.
  • Beckmann K; Global Clinical Operations, Mylan Healthcare GmbH, Freundallee 9A, 30173, Hannover, Germany.
  • Sharma R; Global Product Safety and Risk Management, Mylan, Building 4 Trident Place, Mosquito Way, Hatfield, AL10 9UL, UK.
  • Baczkowski M; Product Safety and Risk Management, Mylan, 781 Chestnut Ridge Road, Morgantown, WV, 26505, USA.
  • Kothekar M; Clinical Development, Biocon Research Ltd, 131, Jigani Road, RK Twp, Bommasandra Industrial Area, Bangalore, Karnataka, 560099, India.
  • Barve A; Global Clinical Research, Mylan, 1000 Mylan Boulevard, Canonsburg, PA, 15317, USA.
Ann Hematol ; 98(5): 1217-1224, 2019 May.
Article in En | MEDLINE | ID: mdl-30824956
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Full text: 1 Database: MEDLINE Main subject: Polyethylene Glycols / Breast Neoplasms / Biosimilar Pharmaceuticals / Chemotherapy-Induced Febrile Neutropenia / Filgrastim Type of study: Clinical_trials / Incidence_studies / Prognostic_studies Limits: Adult / Aged / Female / Humans / Middle aged Language: En Journal: Ann Hematol Journal subject: HEMATOLOGIA Year: 2019 Type: Article Affiliation country: Germany
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Full text: 1 Database: MEDLINE Main subject: Polyethylene Glycols / Breast Neoplasms / Biosimilar Pharmaceuticals / Chemotherapy-Induced Febrile Neutropenia / Filgrastim Type of study: Clinical_trials / Incidence_studies / Prognostic_studies Limits: Adult / Aged / Female / Humans / Middle aged Language: En Journal: Ann Hematol Journal subject: HEMATOLOGIA Year: 2019 Type: Article Affiliation country: Germany