FDA has been busy preparing for the day when the first biosimilar application is filed. In February, FDA published three draft guidance documents on biosimilars. In May, FDA held a public hearing on the guidance. And earlier this week, FDA announced biosimilar user fee rates for fiscal year 2013.
Patent lawyers have been busy preparing too. On September 11th, I will be speaking on "Best Practices in Portfolio Management During the Patent Exchange Process" at IIR USA's 13th Annual Business of Biosimilars & Generic Drugs conference, to be held in Boston from September 10-12. According to the conference producer:
Initially established in 1999 as "The Generic Drugs Summit," this event from the outset helped shape best practice and performance standards in the generics industry. In early years, a major topic of discussion was the potential for "biogenerics," with the biotech industry hoping that these molecules could be created and approved through long-tested and familiar methods. When it became clear that a radically different pathway would be required, we became the first commercial event to address the regulatory and commercialization concerns relevant to follow-on biologics, under our new banner, "The Business of Biosimilars and Biobetters." Now building off the accumulated expertise of our long history, we are proud to offer "The Business of Biosimilars and Generic Drugs" in order to illuminate the most urgent and timely topics relevant to follow-on biopharmaceuticals. This year's program features crossover topics of interest to both groups, as well as breakout sessions to give equal time when their needs diverge.