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Biosimilars Consultation

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EMA Seeks Input on a “Tailored Clinical Approach” in Biosimilar Development

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On April 1, 2025, the European Medicines Agency opened the consultation period for its draft reflection paper on a tailored clinical approach in biosimilar development....more

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Ireland's Department of Health is Requesting Comments Regarding Its National Biosimilars Medicines Policy

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Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable...more

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