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With an unsettled regulatory environment, and a troublesome development path, Biosimilars continues to be an area of the generic drug business that needs careful monitoring. We are able to analyse and report on this rapidly evolving sector, keeping our customers appraised of significant developments and their place in the wider industry.

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Biosimilars Business Review

Biosimilars Business Review

Whereas the EU has outlined a settled policy and regulatory pathway, the USA is at a far earlier stage. Legislation was finally passed by Congress in 2010, but the FDA is still engaged in consultations on ...
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