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Latest From Market Access
African health ministers have agreed on a treaty to set up a new pan-African agency to coordinate regional drug regulatory harmonization initiatives and pool limited regulatory expertise.
Greater Acceptance Of Extrapolation & Switching Boosts Biosimilars But Barriers Remain, Says Sandoz Exec
The biosimilars market is being boosted as physicians become more accepting of biosimilar switching and more willing to prescribe biosimilars on the basis of extrapolation of indications,. However, barriers – including misinformation – remain, as Carol Lynch, president of Sandoz US and chair of the biosimilar medicines group at Medicines for Europe, tells the Pink Sheet.
New guidance from the European Medicines Agency explains how sponsors that have drugs in its priority medicines scheme should interact with its experts and committees.
The European Medicines Agency’s priority medicines scheme, PRIME, attracts a lot of applications, but most of them fail. The agency has explained why and has updated it guidance documents for applicants.
With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
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