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Biosimilarity vs. “Cognitive Dissonance”: The Ongoing Challenges to New FDA Pathway

 
• By Michael McCaughan

FDA is still awaiting its first biosimilar product application – and there is no reason to expect a flood of products any time soon. The new pathway faces legal, logistical and resource obstacles. But the most important barrier may be the need for a mindset change.

Center for Drug Evaluation & Research Director Janet Woodcock kicked off her presentation to an FDA/Drug Information Association meeting on the new biosimilar regulatory process with a detailed history lesson.

She recounted the history of CDER's work in building the pathway, which—in her mind, at least—began nearly a decade ago with a public worksop held in September 2004 on "Scientific

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