On May 23, 2019 Ha Kung Wong was quoted in AJMC regarding congressional action on the Purple Book as the FDA continues its efforts to promote biosimilar uptake in the United States.
According to the article, the FDA is planning an enhanced version of its Purple Book, which is to biologics and biosimilars what the Orange Book is to generic, branded prescription, and over-the-counter drugs.
Wong noted that the Purple Book is the subject of pending congressional action. The House of Representatives unanimously cleared The Purple Book Continuity Act of 2019 earlier this month. If passed, it would require the FDA to add more detailed information on biological products and make the data available in a searchable, electronic format. The Senate has also passed a similar bill, the Biologic Patent Transparency Act.
Both bills are aimed at untangling the so-called patent thickets that critics say stymie pharmaceutical competition and keep drug prices high.