By Kurt R. Karst – If you guessed that the cover of the publication listing biological products licensed under the Public Health Service Act (“PHS Act”), including licensed biosimilar and interchangeable biological products, would be “purple,” then you guessed correctly. The “Purple Book,” which is more …
By James E. Valentine* & James C. Shehan — On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors …
By Kurt R. Karst – Earlier this year we posted on two pending lawsuits brought by potential biosimilar applicants challenging the the so-called “patent dance” patent resolution provisions added to the PHS Act by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). The BPCIA …
The American Conference Institute (“ACI”) will hold its 5th annual Summit on Biosimilars from June 5-6, 2014 at the InterContinental New York Barclay, New York, New York, and a pre-conference primer on June 4th with sessions titled “Biosimilars 101: Comprehensive Deep Dive Into the Relevant …
