A joint Senate committee hearing on fighting the Ebola epidemic in West Africa opened on a grim note Tuesday as Sen. Tom Harkin (D-Iowa) shared the World Health Organization's (WHO) prediction that the epidemic could spread to 20,000 people by the first of December.
Shaking up the color wheel, the FDA released what it's calling the Purple Book – a listing of biologics that may serve as reference products for biosimilars and interchangeables.
Even with a concerted international effort, it may take several months to stop the Ebola epidemic that has claimed nearly 1,000 lives. And there may be more cases in the U.S. That's not the news the House Foreign Affairs Subcommittee on Africa wanted to hear as members interrupted their vacation for an update Thursday on the crisis gripping Guinea, Liberia and Sierra Leone.
The biosimilar pipeline is starting to flow in the U.S. with the FDA receiving its second 351(k) biologic license application (BLA) in less than a month. Celltrion Inc. reported Monday that it has filed a BLA for its Remsima, a biosimilar of Janssen Biotech Inc.'s Remicade (infliximab).
It's not set in stone yet, but the World Health Organization (WHO) is proposing a voluntary, global naming scheme for biologics, both novel and biosimilar.
On the heels of a letter from five senators urging the FDA and Health and Human Services (HHS) to issue guidance to speed biosimilar development, the agency released a draft guidance Monday to make it easier to determine the date of first licensure of the reference biologic.
