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Europa perderá 12.530 millones de euros por vencimiento de patentes farmacéuticas hasta 2029
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Entre 2024 y 2029, la industria farmacéutica europea enfrentará la caducidad de varias de sus patentes más rentables, un proceso que pondrá fin al monopolio de medicamentos emblemáticos y reducirá de manera significativa los ingresos de los laboratorios. Según proyecciones de la consultora IQVIA, los cinco principales mercados España, Alemania, Francia, Italia y Reino Unido dejarán de facturar alrededor de 12.530 millones de euros. Aunque el impacto económico es evidente, la apertura de mercado para biosimilares y genéricos abre una oportunidad única de ahorro y acceso para los sistemas de salud y los pacientes. La clave estará en la innovación, la fortaleza del pipeline de alternativas y la capacidad regulatoria de Europa para evitar desigualdades en la adopción.
Pérdidas millonarias en los grandes laboratorios
El informe de IQVIA detalla un escenario que compromete a los fármacos más vendidos en el mundo. Stelara (ustekinumab), de Johnson & Johnson, utilizado para la psoriasis en placas, pierde su patente en 2025. Desde 2019 ha sido el producto insignia del laboratorio, que ya trabaja en el desarrollo de 25 nuevos medicamentos para sostener un crecimiento de entre 5 % y 7 % anual en el periodo 2025-2030.
Otro caso emblemático es Keytruda (pembrolizumab), de MSD, considerado el medicamento más vendido del mundo. Su exclusividad expira en 2028 y, según Evaluate Pharma, sus ingresos caerán de 25.450 millones de euros en 2024 a 14.580 millones en 2030. Para mitigar la pérdida, la farmacéutica apuesta por una formulación subcutánea que podría recuperar alrededor de 6.560 millones.
La misma situación afrontará Opdivo (nivolumab), de Bristol Myers Squibb, a partir de 2030. La compañía ha desplegado una estrategia diversificada que incluye una formulación subcutánea, un acuerdo con BioNTech para co-desarrollar un nuevo tratamiento contra cánceres sólidos y adquisiciones multimillonarias como Karuna Therapeutics (12.000 millones) y Mirati Therapeutics (5.000 millones).
En el campo de las vacunas, Shingrix (GSK) contra el herpes zóster dejará un vacío estimado en 22.210 millones de euros, mientras que Prevnar (Pfizer), dirigida contra el neumococo, perderá ingresos por alrededor de 17.648 millones. Por su parte, Roche afrontará una caída de 17.939 millones por la pérdida de exclusividad de su terapia para la esclerosis múltiple.
En el segmento de diabetes, la estadounidense Lilly verá expirar en 2027 la patente de Trulicity, lo que supondrá una merma de 11.100 millones de euros. Un año después, la francesa Sanofi dejará de percibir cerca de 5.120 millones por la caducidad de Toujeo, su insulina glargina.
Biosimilares y genéricos: el relevo necesario
La pérdida de patentes abre espacio a la competencia de biosimilares y genéricos, clave para reducir el gasto sanitario y ampliar el acceso a terapias avanzadas. En España, se prevé que 27 moléculas contarán con versiones biosimilares en los próximos cinco años, lo que podría generar ahorros de hasta 22.270 millones de euros hasta 2030, de acuerdo con la Asociación Española de Biosimilares (Biosim).
El mayor impacto lo tendrán los biosimilares de adalimumab, con un ahorro proyectado de 1.152,9 millones de euros. También destacan las alternativas de ustekinumab, infliximab, rituximab y bevacizumab.
Sin embargo, el panorama no está exento de riesgos. IQVIA advierte de un “vacío de biosimilares”: hasta 2032, medicamentos biológicos por un valor de 30.000 millones de euros perderán exclusividad en Europa, pero la mitad no cuenta con un pipeline de competencia activo, lo que podría limitar en 15.000 millones de euros el ahorro potencial para los sistemas de salud.
Además, la adopción de biosimilares no es homogénea. La penetración es más rápida en tratamientos hospitalarios de uso agudo, mientras que en las farmacias comunitarias la transición es más lenta. En España, Andalucía y Cataluña lideran la cuota de mercado, mientras que Comunidad Valenciana y Murcia registran una menor incorporación de estas alternativas.
Desafíos regulatorios y barreras de adopción
El marco normativo europeo mantiene una gran heterogeneidad que afecta la entrada de biosimilares y genéricos. Cada país establece requisitos distintos, lo que se traduce en desigualdades en disponibilidad, gasto y acceso. Incluso en España, las diferencias entre comunidades autónomas son notorias.
Expertos señalan que la falta de armonización regulatoria y la escasa formación clínica sobre biosimilares generan desconfianza entre profesionales y pacientes. Sin políticas claras que fomenten la competencia y reinviertan los ahorros en innovación y cobertura, gran parte del potencial económico podría diluirse.
Un equilibrio entre riesgo y oportunidad
El vencimiento de patentes clave en Europa hasta 2029 plantea un desafío financiero de gran magnitud para las farmacéuticas, que buscan respuestas en nuevas formulaciones, adquisiciones estratégicas y diversificación de su portafolio.
Para los sistemas de salud, este escenario representa una oportunidad histórica: la competencia de biosimilares y genéricos podría liberar miles de millones de euros que, gestionados de forma eficiente, permitirían ampliar la cobertura, garantizar el acceso y reforzar la sostenibilidad. No obstante, el riesgo de un “vacío de biosimilares” y la fragmentación normativa europea amenazan con limitar estos beneficios.
La clave estará en fortalecer la confianza clínica, unificar los marcos regulatorios y asegurar que los ahorros se traduzcan en acceso equitativo e innovación real. Solo así, la pérdida de patentes se transformará en una palanca de sostenibilidad para los sistemas sanitarios europeos.
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