Reuters is reporting that the FDA’s Arthritis Advisory Board has unanimously recommended Amgen’s biosimilar of AbbVie’s Humira, ABP 501. The panel said that the drug was similar in safety and effectiveness to Humira for rheumatoid arthritis and plaque psoriasis, and it recommended that the biosimilar should also be approved for Crohn’s disease in adults and ulcerative colitis. (Reuters)
Stansel has previously served as acting general counsel for the Dept. of Health and Human Services, working as the chief legal officer for it and several sub-agencies including the Food and Drug Administration.
Based on Medicare adherence numbers among diabetic patients, the IMS Institute estimates that complications from type 2 diabetes will cost about $100 billion annually in the United States, with $4 billion attributable to Medicare patients.
The move is aimed at Nichi-Iko becoming one of the top 10 global generics leaders, and the companies said acquiring Sagent will boost Nichi-Iko’s ability to commercialize its biosimilar pipeline and increase its presence in injectables.