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A. Schwendeman

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Review Open access Sep 2026

Importance of Single Global Regulatory Standards for the Assessment of Generic and Biosimilar Medicines to Advance Patient Access

Generic and biosimilar medicines are foundational to sustainable healthcare, enabling broader patient access globally through high-quality, cost-effective alternatives. However, their market access is hindered by regulatory fragmentation across major authorities, where regulatory expectations are not always clearly ali...

Antonela Rodriguez, Vishalakshi Krishnan, James E. Polli et al. · 0 citations

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