Tuesday, November 3, 2009

Pending Legislation- "Biosimilar" Products and Market Exclusivity

Legislative committees in both the Senate and the House approved bills that would authorize the FDA to create an approval pathway for follow-on biologic, or "biosimilar," products that would guarantee manufacturers 12 years of market exclusivity for a new biologic agent before any biosimilar product could be approved, even in the absence of a valid patent. Manufacturers could also obtain an additional 12-year exclusivity period by making minor changes to the structure of an approved product, such as those that could lead to changes in administration schedules (e.g., from weekly to monthly). Supporters argue that these much longer periods of protection from competition are fair because the development higher costs for biologic medications.  I have listed a variety of summaries and opinion pieces about this legislation below:

What is your opinion on this bill?  How will it impact your patent strategy or your clients strategy? Join the conversation on this subject by leaving a comment or provide a link to additional summaries or commentary.  If you do not have a Google account or wish to remain Anonymous, use the Anonymous setting.


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