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R. Aparicio Hernández, et al. 25. EMA Besponsa. Summary of opinion1 (initial authorisation). Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/004119/WC500226203.pdf 26. Committee for Orphan Medicinal Products (COMP).Disponible en: http:// www.ema.europa.eu/docs/en_GB/document_library/Committee_meeting_ report/2017/05/WC500228270.pdf 27. Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W et al. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lympho-blastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. 28. Hemophilia News Today. Disponible en: https://hemophilianewstoday.com/ refixia-n9-gp/ 29. EMA. Committee for Medicinal Products for Human Use (CHMP). Sum-mary of opinion (initial authorisation) for Spinraza®. Disponible en: http:// www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opi-nion_-_ Initial_authorisation/human/004312/WC500226191.pdf 30. EMA. EPAR for Spinraza®. Disponible en: http://www.ema.europa.eu/ docs/en_GB/document_library/EPAR_-_Public_assessment_report/hu-man/ 004312/WC500229706.pdf 31. Hoy SM. Nusinersen: First Global Approval. Drugs. 2017 Mar;77(4):473-479. 32. Bishop KM, Montes J, Finkel RS. Motor milestone assessment of infants with spinal muscular atrophy using the hammersmith infant neurological Exam-Part 2: Experience from nusinersen clinical study. Muscle Nerve. 2017 May 26. Disponible en: https://www.ncbi.nlm.nih.gov/pubmed/28556387 33. First New Medicine for the Treatment of Hyperkalemia in More than 50 Years. Disponible en: http://www.relypsa.com/our-medicine/veltassa/ 34. Relypsa, Inc. Veltassa label. Disponible en: https://www.veltassa.com/pi.pdf 35. U S Food and Drug Administration. Elmiron® Label. Disponible en: https:// www.accessdata.fda.gov/drugsatfda_docs/label/2008/020193s009lbl.pdf 36. EMA. Committee for Medicinal Products for Human Use (CHMP). Sum-mary of opinion (initial authorisation) for Riximyo®. Disponible en: http:// www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opi-nion_-_ Initial_authorisation/human/004729/WC500226218.pdf 172  Sanid. mil. 2017; 73 (3) 37. EMA. CHMP summary of positive opinion for Rixathon®. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/003903/WC500226219.pdf 38. Visser J, et al. Physicochemical and Functional Comparability Between the Proposed Biosimilar Rituximab GP2013 and Originator Rituximab. Bio- Drugs. 2013; 27: 495-507. 39. Da Silva A, et al. Target-directed development and preclinical characteriza-tion of the proposed biosimilar rituximab GP2013. Leuk Lymphoma. 2014; 55: 1609-1617. 40. Wojciech J., Moreira I., Kanaka S., Munhoz E.,Echeveste MA., Pratyush G. et al. A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma. American Society Hematology. 58th anual meeting and exposition. San Diego, CA. Disponible en : https://ash.confex. com/ash/2016/webprogram/Paper89113.html 41. EMA. Committee for Medicinal Products for Human Use (CHMP). Sum-mary of opinion-Initiala authorisation for Kevzara®. Disponible en: http:// www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opi-nion_-_ Initial_authorisation/human/004254/WC500226186.pdf 42. Genovese MC, Fleischmann R, Kivitz AJ, Rell Bakalarska M, Martincova R, Fiore S et al. Sarilumab Plus Methotrexate in Patients With Active Rheu-matoid Arthritis and Inadequate Response to Methotrexate: Results of a Phase III Study. Arthritis Rheumatol. 2015 Jun;67(6):1424-37. 43. EMA. EPAR for Kevzara®. Disponible en: http://www.ema.europa.eu/ docs/en_GB/document_library/EPAR_-_Public_assessment_report/hu-man/ 004254/WC500230070.pdf 44. EMA. CHMP summary of positive opinion for Cuprior®. Disponible en: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_ opinion_-_Initial_authorisation/human/004005/WC500226178.pdf 45. U S Food and Drug Administration. Trumenba® Label. Disponible en: https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approved-products/ ucm421139.pdf


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