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Retos en el Uso de Biosimilares
¡Gracias por escuchar! La disponibilidad de biosimilares para tratar enfermedades inflamatorias ha generado nuevos retos en la terapéutica de pacientes cuando se sustituye el tratamiento de un bio-original a su biosimilar (o bio comparable en México) para ahorrar costos. En este episodio hablaré acerca de la evidencia sobre la la efectividad y la seguridad del 'cambio no médico' de fármacos y sobre los beneficios de comunicar información sobre biosimilares a los pacientes de manera positiva.
Recuerden que su retroalimentación y sus calificaciones en iTunes son bienvenidas.
Aquí están las referencias consultadas:
1. European Medicines Agency. Centrally authorised biosimilar medicines. EMA https://www.ema.europa.eu/ en/medicines/field_ema_web_categories%253Aname_ field/Human/ema_group_types/ema_medicine/field_ ema_med_status/authorised-36/ema_medicine_types/ field_ema_med_biosimilar/search_api_aggregation_ ema_medicine_types/field_ema_med_biosimilar (2019).
2. US Food & Drug Administration. Biosimilar product information. FDA https://www.fda.gov/drugs/ biosimilars/biosimilar-product-information (2019).
3. Dorner, T. & Kay, J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat. Rev. Rheumatol. 11, 713–724 (2015).
4. Goll, G. L. et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J. Intern. Med. 285, 653–669 (2019).
5. Glintborg, B. et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann. Rheum. Dis. 78, 192–200 (2019).
6. Gasteiger, C. et al. The effects of message framing on patients’ perceptions and willingness to change to a biosimilar in a hypothetical drug switch. Arthritis Care Res. https://doi.org/10.1002/acr.24012 (2019).
7. Jørgensen, K. K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, doubleblind, non-inferiority trial. Lancet 389, 2304–2316 (2017).
8. Radet for Anvendelse af Dyr Sygehusmedicin. RADS anbefaling vedrørende brug af biosimilært infliximab og etanercept [RADS recommendation regarding the use of biosimilar infliximab and etanercept]. regioner.dk https://www.regioner.dk/media/3488/rads-notatom-anvendelsen-af-biosimilaere-juni-2016.pdf (2016).
9. Tweehuysen, L. et al. Open-label, non-mandatory transitioning from originator etanercept to biosimilar SB4: six-month results from a controlled cohort study. Arthritis Rheumatol. 70, 1408–1418 (2018)
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By Daniel Xibille Friedmann¡Gracias por escuchar! La disponibilidad de biosimilares para tratar enfermedades inflamatorias ha generado nuevos retos en la terapéutica de pacientes cuando se sustituye el tratamiento de un bio-original a su biosimilar (o bio comparable en México) para ahorrar costos. En este episodio hablaré acerca de la evidencia sobre la la efectividad y la seguridad del 'cambio no médico' de fármacos y sobre los beneficios de comunicar información sobre biosimilares a los pacientes de manera positiva.
Recuerden que su retroalimentación y sus calificaciones en iTunes son bienvenidas.
Aquí están las referencias consultadas:
1. European Medicines Agency. Centrally authorised biosimilar medicines. EMA https://www.ema.europa.eu/ en/medicines/field_ema_web_categories%253Aname_ field/Human/ema_group_types/ema_medicine/field_ ema_med_status/authorised-36/ema_medicine_types/ field_ema_med_biosimilar/search_api_aggregation_ ema_medicine_types/field_ema_med_biosimilar (2019).
2. US Food & Drug Administration. Biosimilar product information. FDA https://www.fda.gov/drugs/ biosimilars/biosimilar-product-information (2019).
3. Dorner, T. & Kay, J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat. Rev. Rheumatol. 11, 713–724 (2015).
4. Goll, G. L. et al. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J. Intern. Med. 285, 653–669 (2019).
5. Glintborg, B. et al. To switch or not to switch: results of a nationwide guideline of mandatory switching from originator to biosimilar etanercept. One-year treatment outcomes in 2061 patients with inflammatory arthritis from the DANBIO registry. Ann. Rheum. Dis. 78, 192–200 (2019).
6. Gasteiger, C. et al. The effects of message framing on patients’ perceptions and willingness to change to a biosimilar in a hypothetical drug switch. Arthritis Care Res. https://doi.org/10.1002/acr.24012 (2019).
7. Jørgensen, K. K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, doubleblind, non-inferiority trial. Lancet 389, 2304–2316 (2017).
8. Radet for Anvendelse af Dyr Sygehusmedicin. RADS anbefaling vedrørende brug af biosimilært infliximab og etanercept [RADS recommendation regarding the use of biosimilar infliximab and etanercept]. regioner.dk https://www.regioner.dk/media/3488/rads-notatom-anvendelsen-af-biosimilaere-juni-2016.pdf (2016).
9. Tweehuysen, L. et al. Open-label, non-mandatory transitioning from originator etanercept to biosimilar SB4: six-month results from a controlled cohort study. Arthritis Rheumatol. 70, 1408–1418 (2018)