As discussed in several entries in this blog, the data exclusivity provision in the follow-on biologics pathway are being much discussed by branded and generic manufacturers, public and private payers - and the Senate has gotten into both sides of the act.
The "branded side" interprets the healthcare bill as endowing them with 12 yrs of data exclusivity for their branded products and also the possibility of extending this another 12 years by significantly altering a product's safety or efficacy profile. Thus, the branded biologics manufacturer would be protected from having a generics producer using any of their data package for at least 12 years -- and thus new generic products would take even longer than that to reach the market.
The "generics and payers side" interprets the legislation as affording the branded manufacturer 4 years of data exclusivity and an additional 8 years of market exclusivity. The generic manufacturer could thus start their application well in advance of the 12 yr market exclusivity window and be ready to launch when the 12 year mark expired.
Needless to say there is a lot of money involved here for both sides, and the lines are being drawn to stake out the lobbying position one way or another with the Congress to influence the FDA decision on what final regulations will be adopted for biosimilars. We can expect to see more jostling and wrangling for the foreseeable future. See Patent Doc blog, Fierce Biotech and WSJ for more.
When it comes to writing legislation, Senators might try to mean what they say and say what they mean.
Posted by Bruce Lehr Jan 26th 2011.