Aparicio Hernández R., et. al. 35. EMA/CHMP. Disponible en: https://www.ema.europa.eu/documents/smop-initial/ chmp-summary-positive-opinion-apealea_en.pdf 36. Oasmia®. Nota de prensa 2018. Disponible en: https://prlibrary-eu.nasdaq. com/Resource/Download/6a269e98-ce7b-43c1-b29c-af0b9d8a7d15 37. Singla AK, Garg A, Aggarwal D. Paclitaxel and its formulations. Int J Pharm 2002; 235: 179-92. 38. Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: The drawbacks and advantages of vehicle selection for drug formulation. Eur J Cancer 2001; 37: 1590-8. 39. Gradishar WJ. Albumin-bound paclitaxel: A next-generation taxane. Expert Opin Pharmacother 2006; 7: 1041-53. 40. Asociación Española de Biosimilares. Disponible en: https://www.biosim.es/ medicamentos-biosimilares-aprobados-por-la-comision-europea-filgrastim/ 41. EMA, Introducción a los medicamentos biosimilares. Disponible en: http:// www.ema.europa.eu/. Consultado el 21 de diciembre de 2018. 42. Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, et al. A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim. J Can-cer Res Clin Oncol. 2018 Jun;144(6):1087-1095. 43. Waller, C. et al. Phase 3 efficacy and safety trial of proposed pegfilgrastim bio-similar MYL-1401H vs EU-Neulasta® in the prophylactic treatment of che-motherapy- induced neutropenia. European Journal of Cancer, Volume 72, S42 Disponible en: https://www.ejcancer.com/article/S0959-8049(17)30217-4/ pdf 44. European Medicines Agency.European Public Assessment Report. Acce-so 05/01/2019.Disponible en: https://www.ema.europa.eu/documents/as-sessment- report/pelmeg-epar-public-assessment-report_en.pdf 45. Harbeck N, Lipatov O, Frolova M, Udovitsa D, Topuzov E, Ganea-Motan DE, et al. Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. Future Oncol. 2016 Jun;12(11):1359-67. 46. Harbeck N, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, et al. Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an ex-ploratory 26 Sanid. mil. 2019; 75 (1) comparison from two Phase III trials. Future Oncol. 2017 Jul;13(16):1385-1393. 47. Blackwell K, Donskih R, Jones CM, Nixon A, Vidal MJ, Nakov R, et al. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgras-tim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemothera-py: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double- Blind Trial. Oncologist. 2016 Jul; 21(7):789-94. 48. EMA/CHMP/688548/2018. Ogivri®. Disponible en: https://www.ema.europa. eu/documents/smop-initial/chmp-summary-positive-opinion-ogivri_en.pdf 49. Rugo HS, Barve A, Waller CF, Hernández-Bronchud M, Herson J, Yuan J, et al. Effect of a proposed trastuzumab biosimilar compared with trastuzumab on overall response rate in patients with ERBB2 (HER2)-positive metastatic breast cancer: a randomized clinical trial. JAMA 2017; 317: 37-47. 50. WHO. Dengue Vaccines.Consultado el 14.01.2018. Datos disponibles: https:// www.who.int/immunization/research/development/dengue_q_and_a/en/ 51. EMA. European Public Assesment Report DENGVAXIA®. Disponible en: https://www.ema.europa.eu/documents/assessment-report/dengvaxia-epar-public- assessment-report_en.pdf 52. European Medicines Agency (EMA).Committe for Medical Products for Humans (CHMP) .Committe for advanced therapies and Committee. Lu-xturna ®. Disponible en: https://www.ema.europa.eu/en/medicines/human/ summaries-opinion/luxturna 53. Russell S, Bennett J, Wellman JA, Chung DC, Yu ZF, Tillman A et al. Effi-cacy and safety of voretigene neparvovec (AAV2-hRPE65v2) in patients with RPE65-mediated inherited retinal dystrophy: a randomised, controlled, open-label, phase 3 trial. Lancet. 2017 Aug 26;390(10097):849-860. Erratum in: Lancet. 2017 Aug 26;390(10097):848. Disponible en: https://www.ncbi. nlm.nih.gov/pmc/articles/PMC5726391/ 54. Ameri H. Prospect of retinal gene therapy following commercialization of voretigene neparvovec-rzyl for retinal dystrophy mediated by RPE65 muta-tion. J Curr Ophthalmol. 2018 Feb 16;30(1):1-2. Disponible en: https://www. ncbi.nlm.nih.gov/pmc/articles/PMC5859497/pdf/main.pdf
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