14 October 2020 - Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. 

Now a new analysis, published in the Mayo Clinic Proceedings, suggests that a “high testing bar” for biosimilars to gain regulatory approval is another contributing factor.

The analysis found that the median time from the start of a Phase I study to approval by the US FDA was more than 5 years.

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