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Woodcock: Concerns About US FDA's Biosimilars Suffix Policy Detached From Reality

 
• By Michael Cipriano

In an exclusive interview, Center for Drug Evaluation and Research Director Janet Woodcock contends that industry concerns about FDA's new suffix policy aren't reflective of real-world problems.

Close up of old English dictionary page with word suffix

Biosimilar developers were displeased when the US FDA recently decided that it would no longer change the nonproprietary names of innovator biologicals that were initially approved without a random four-letter suffix. But Center for Drug Evaluation and Research (CDER) Director Janet Woodcock suggested that these objections could represent a disconnect between industry stakeholders and the prescriber and patient communities confronted with real-world problems.

In an exclusive interview with the Pink Sheet about the policy change, Woodcock asserted that practitioners are not worried about whether a product has a suffix, but rather the value of a biosimilar product

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