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Side Step-Wise Development: Sponsors Aren’t Using FDA’s Preferred Approach To Biosimilars

 
• By Derrick Gingery

Rather than conduct most analytical characterization and non-clinical studies first, the hallmark of the US FDA approach, biosimilar sponsors are often initiating clinical trials about the same time.

Steps
The approach is not working from a 'chronological' standpoint, Sarah Yim said. • Source: Shutterstock

After more than a decade, the US FDA’s vaunted step-wise approach to biosimilar development is not being used as intended, which may be hindering the sector’s growth and limiting pricing pressure on originator biologics.

The FDA wants biosimilar sponsors to analytically characterize their biosimilar candidates before conducting clinical trials, which can help eliminate uncertainty and potentially reduce the number or size of the studies...

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