Incentives for Filing a Product Through the 351(k) Pathway
November 16th 2013Steven Lucio of Novation discusses how Teva's Granix (tbo-filgrastim), which was filed through a 351(a) pathway, was approved for only 1 indication--and it was not the indication considered to be the "most definitive" for that particular product.
Hepatitis C: Patient Warehousing
November 16th 2013Aimee Tharaldson of Express Scripts explains why some hepatitis C patients who do not have signs of active disease may want to wait to receive treatment until later this year and early next year, when the FDA is expected to approve sofosbuvir and simeprevir for the treatment of this condition.
Manufacturing Patents for Biosimilar Products
November 15th 2013Manufacturing patents will play a larger role than molecule patents within the biologics development process, and these will also be a factor in terms of bringing complex products to market, argued Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.
Formulary Analysis of Biosimilars: What Will the Process Involve?
November 14th 2013The process of adding biosimilars to formularies will be much more rigorous than what the industry is accustomed to seeing in the generic molecule space, asserted Steven Lucio, senior director, Clinical Solutions and Pharmacy Program Development at Novation.