Make The ‘Purple Book’ More Orange, US FDA Told At Biosimilars Hearing
Listing patent and exclusivity information for novel biologics, as is done in the ‘Orange Book’ for small molecules, would help inform biosimilar development, stakeholders say at hearing on facilitating biologic competition and innovation; AbbVie urges FDA to use the Purple Book to clarify the scope of interchangeability decisions.
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One of US FDA’s most important publications ever, the Orange Book celebrates 40 years as the definitive guide to approved drug products and therapeutic equivalents. Even as the color has receded from the book itself, orange still generates appreciation from regulators and outside attorneys.
BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
Playing It Safe? Hahn's Biosimilar View
US FDA Commissioner nominee gave a general, scripted answer to a question about biologic patents, but did Stephen Hahn inadvertently go against the agency's stance on the issue?