Datamonitor: Biosimilars Series

Strategic Issues

Product Description:

Development of biosimilars is a long and complex process. Timely and thorough analysis of challenges and potential pitfalls is crucial to minimize costs and risks. With five approved biosimilars, Europe serves as a model for other countries looking to define their own regulatory approval criteria. The US is on the brink of passing legislation to establish a statutory pathway for biosimilars approval. However, the opposing interests of biosimilar and innovative companies may result in further delays to the entry of biosimilars.

Datamonitor's Biosimilars Series: Strategic Issues provides in-depth analysis of the biosimilars regulatory environment in Europe and the US and analyzes the challenges biosimilar manufacturers are facing during development.

This special report provides in-depth analysis of the biosimilars regulatory environment in Europe and the US and analyzes the challenges biosimilar manufacturers are facing during development.

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ORDER CLASS: BIOS
SOURCE CODE: EHCM

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