The agency has outlined its Orphan Drug Modernization plan, which it said is part of a larger effort called the Medical Innovation Development plan modernize and make efficient the FDA’s regulatory tools and policies.
Rituxan Hycela contains hyaluronidase human, an enzyme that helps with the subcutaneous delivery of Rituxan's active ingredient, rituximab, allowing for faster administration compared with intravenous Rituxan.
The Supreme Court has overturned an appeals court decision which said Sandoz had to wait 180 days under federal law after receiving Food and Drug Administration approval to launch its biosimilar of Amgen’s Neupogen (filgrastim), Zarxio (filgrastim-sndz).
The latest report on generics cost savings, compiled by the QuintilesIMS Institute on behalf of the Association for Accessible Medicines, highlights the key role generics play in healthcare cost savings.
According to the QuintilesIMS Institute’s 2017 Medicine Use and Spending report, Truvada had $3.1 billion in sales on an invoice price basis in 2016, ranking 17th among the top 20 medicines in the U.S. based on invoice spending.