Monthly Round-Up of What to Read on Pharma Law and Policy
Topics include the association between the clinical benefit of cancer drugs and their prices, and whether to include children in COVID-19 therapy trials.
Biosimilars
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Read more: Biosimilars – In The Pipeline or Still a Pipe Dream? Biosimilars – In The Pipeline or Still a Pipe Dream?
By Jonathan Larsen, JD, MPP and Adrienne R. Ghorashi, Esq. The US Food and Drug Administration (FDA) approved the first biosimilar for use in the United States in March 2015. The approval came after several years of regulatory process development authorized by the Biologics Price Competition and Innovation (BPCI) Act of 2009, a component of…
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Read more: Rapid Rise in IND’s for Biosimilars Rapid Rise in IND’s for Biosimilars
By Bob Bohrer [Cross-posted on Pharmaceutical Policy.] According to a story by Bronwyn Mixter in Bloomberg’s BNA BIOTECH WATCH, the FDA has received at least twenty-five IND’s for biosimilar development programs. Some quick perspective on that is appropriate. Twenty-five initial IND’s for the development of new small molecule drugs for cancer or autoimmune disease would face…