Biosimilars: developments in the EU and US

Resource type: Article

Status: Law stated as at 01-Oct-2008

Whether biosimilars should be approved by relying on data developed by sponsors of the innovator biologics that they "copy" has been controversial in the EU and in the US. Since the new European pharmaceutical law, the EU has moved forward to create a route for such approvals. In the US, it is likely that a new biosimilars statutory framework will receive serious consideration. This chapter examines the EU biosimilar approval regime, debate surrounding the naming of biosimilar products, and legislative biosimilars proposals in the US Congress.
Lincoln Tsang and Daniel Kracov, Arnold & Porter LLP

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